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24-02-2025
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Teva and Sanofi Present New Positive Phase 2b Study Results at ECCO 2025 Reinforcing Best-in-Class Potential of Duvakitug (Anti-TL1A) in Ulcerative Colitis and Crohn's Disease
Teva hosting investor call Monday, February 24 at 8:00 a.m. U.S. ET New detailed data from the RELIEVE UCCD study support overall efficacy and safety of duvakitug in all pre-specified subgroups across the different doses New endpoints presented include findings on clinical and endoscopic outcomes and histological- endoscopic mucosal improvement Findings to form the basis for a Phase 3 program, anticipated to start in H2 2025 PARSIPPANY, N.J. and PARIS, Feb. 22, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Sanofi today presented new, detailed results from the RELIEVE UCCD Phase 2b study of duvakitug (TEV'574/SAR447189), a human IgG1-λ2 monoclonal antibody targeting TL1A, for the treatment of moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD), the two most common forms of inflammatory bowel disease (IBD). These results were shared in two oral presentations at the 20th Congress of the European Crohn's and Colitis Organisation (ECCO) in Berlin, Germany.1, 4 Ulcerative colitis In the UC cohort of the RELIEVE UCCD study, 36% (450 mg dose) and 48% (900 mg dose) of patients treated with duvakitug achieved the primary endpoint of clinical remission (mMS)* at week 14 compared to 20% treated with placebo; placebo-adjusted rates were 16% (450 mg) and 27% (900 mg) (p=0.050 and 0.003, respectively).1-3 In addition, higher clinical remission rates were observed for both doses of duvakitug versus placebo in both advanced therapy (AT)-experienced and AT-naïve subgroups of patients. AT-experienced: 29% (450 mg) and 36% (900 mg), with placebo-adjusted rates of 22% (450 mg) and 29% (900 mg). AT-naïve: 39% (450 mg) and 53% (900 mg), with placebo-adjusted rates of 12% (450 mg) and 26% (900 mg).1-3 Additional endpoints observed*: Clinical response (mMS): 81% (450 mg) and 70% (900 mg) compared to 52% treated with placebo. Endoscopic improvement (MES): 45% (450 mg) and 50% (900 mg) compared to 23% treated with placebo. Histological-endoscopic mucosal improvement (HEMI): 30% (450 mg) and 33% (900 mg) compared to 16% treated with placebo.1-3 'Patients, many of whom have spent years in a recurring cycle of remission and relapse, have been waiting a long time for better options in treating ulcerative colitis. We're highly encouraged by the significant treatment response, compared to placebo seen in the study, both in advanced therapy naïve-and experienced patients,' said Walter Reinisch, MD, PhD, Medical University of Vienna, and lead investigator of the RELIEVE UCCD study. 'With this potential of duvakitug to reduce inflammation, we could truly transform treatment for patients with IBD in a safe manner.' Crohn's disease In the CD cohort of the RELIEVE UCCD study, 26% (450 mg) and 48% (900 mg) of patients with CD treated with duvakitug achieved the primary endpoint of endoscopic response (SES-CD)* compared to 13% on placebo; placebo-adjusted rates were 13% (450 mg) and 35% (900 mg) at week 14 (p=0.058 and <0.001, respectively). In addition, higher endoscopic response rates were observed for both doses of duvakitug versus placebo in both AT-experienced and -naïve subgroups of patients. AT-experienced: 11% (450 mg) and 48% (900 mg), with placebo-adjusted rates of 7% (450 mg) and 44% (900 mg). AT-naïve: 47% (450 mg) and 47% (900 mg), with placebo-adjusted rates of 25% (450 mg) and 25% (900 mg).2-4 Additional endpoints observed: Endoscopic remission (SES-CD): 17% (450 mg) and 26% (900 mg) compared to 9% treated with placebo. Clinical remission (CDAI): 50% (450 mg) and 54% (900 mg) compared to 41% treated with placebo. Clinical response (CDAI): 61% (450 mg) and 62% (900 mg) compared to 41% treated with placebo. Clinical response (PRO2): 50% (450 mg) and 53% (900 mg) compared to 29% treated with placebo.2-4 'Every day, I see patients with Crohn's disease who continue to suffer from the often-severe symptoms of the disease despite available treatments,' said Vipul Jairath, MBChB, DPhil, FRCP, FRCPC, Professor of Medicine in the Departments of Medicine, Epidemiology and Biostatistics at Western University, and lead investigator of the RELIEVE UCCD study. 'The endoscopic response rates seen in this study support the potential of duvakitug as an effective new option for these who are in desperate need of relief.' RELIEVE UCCD safety data summary In both the UC and CD cohorts, duvakitug was generally well tolerated with no emergent safety signals observed.1-4 No dose dependent or adverse event (AE) pattern was observed for treatment-related AEs, serious adverse events (SAEs), AEs leading to discontinuation or adverse events of special interest (AESIs). Duvakitug is currently under clinical investigation, and its efficacy and safety have not been evaluated by any regulatory authority. Teva Investor CallTeva will hold an investor call and live webcast on Monday, February 24, 2025, at 8:00 a.m. ET. During the conference call, Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer, and external IBD key opinion leaders (KOLs) will discuss new data presented for duvakitug (Anti-TL1A) positive Phase 2b results at the 20th Annual Congress of the European Crohn's and Colitis Organization (ECCO). In order to participate, please register in advance here to obtain a local or toll-free phone number and your personal pin. A live webcast of the call will also be available on Teva's website at: Following the conclusion of the call, a replay of the webcast will be available within 24 hours on Teva's website. About Inflammatory Bowel Disease UC and CD, the two main types of IBD, are chronic inflammatory conditions of the GI tract resulting in debilitating and persistent symptoms such as abdominal pain, diarrhea, rectal bleeding, fatigue and weight loss.5,6 Prolonged inflammation can lead to damage within the GI tract, including fibrosis, a common complication of IBD characterized by an accumulation of scar tissue in the intestinal wall, which may cause narrowing and obstruction often requiring hospitalization and surgery. There is currently no cure for IBD – the goal of treatment is to induce and maintain remission and prevent flares.7 About the RELIEVE UCCD Phase 2b Study RELIEVE UCCD was a 14-week Phase 2b, randomized, double-blinded, dose-ranging study to determine the efficacy, safety, pharmacokinetics, and tolerability of duvakitug in adults with moderate-to-severe ulcerative colitis (UC) or Crohn's disease (CD). The study was an innovative and efficient basket study design allowing the inclusion of patients with either type UC and CD. It is also the first and only randomized, blinded and placebo-controlled Phase 2 study to investigate the impact of TL1A in CD. In the study, patients who met pre-specified inclusion criteria were randomized to receive one of two duvakitug doses or placebo, administered every two weeks subcutaneously, in a 1:1:1 ratio for each indication (UC or CD) stratified by previous exposure to advanced IBD therapies [yes (either biologics/small molecule) or no] for 14 weeks. The UC cohort comprised adults with moderately to severely active disease with inadequate response, loss of response or intolerance to previous conventional and/or advanced therapies (ATs). The CD cohort comprised adults with moderately to severely active disease with documented inadequate response, loss of response or intolerance to conventional and/or advanced therapies (ATs). Primary efficacy endpoints are the number of participants who show clinical remission (as defined by the modified Mayo score) in the UC cohort or the number of participants who show endoscopic response (as defined by the SES-CD endoscopic score for CD) in the CD cohort. The study includes sites in the U.S., Europe, Israel, and Asia.2,3 About Duvakitug Duvakitug is a potential best-in-class human IgG1-λ2 monoclonal antibody that targets tumor necrosis factor (TNF)-like ligand 1A (TL1A), also known as TNF superfamily member 15 (TNFSF15). TL1A signaling is believed to amplify inflammation and drive fibrosis associated with inflammatory bowel disease (IBD) through binding its receptor, death receptor 3 (DR3). Duvakitug is uniquely designed to inhibit preferentially TL1A signaling via DR3, with the potential advantage of reduced TL1A-DcR3 inhibition.8 Duvakitug is currently in a Phase 2b clinical study for the treatment of ulcerative colitis (UC) and Crohn's disease (CD), the two most common types of IBD. The safety and efficacy of duvakitug have not been reviewed by any regulatory authority. About the Teva and Sanofi Collaboration Teva and Sanofi are collaborating to co-develop and co-commercialize Teva's duvakitug for the treatment of UC and CD. Each company will equally share the development costs globally, and the net profits and losses in major markets, with other markets subject to a royalty arrangement. Sanofi will lead the Phase 3 clinical development program. Teva will lead commercialization of the product in Europe, Israel and specified other countries, and Sanofi will lead commercialization in North America, Japan, other parts of Asia and the rest of the world. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global pharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company's global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. If patients have a need, we're already working to address it. To learn more about how Teva is all in for better health, visit About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as 'should,' 'expect,' 'anticipate,' 'estimate,' 'target,' 'may,' 'project,' 'guidance,' 'intend,' 'plan,' 'believe' and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop duvakitug (Anti-TL1A) for the treatment of ulcerative colitis (UC) and Crohn's disease (CD), including to proceed to Phase 3 study and obtain required regulatory approvals; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generic medicines; the effectiveness of our patents and other measures to protect our intellectual property rights; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the sections captioned 'Risk Factors' and 'Forward-looking Statements.' Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. *P-values reported are one-sided at a significance level of = modified Mayo Score; MES = Mayo Endoscopic Subscore; HEMI = Histological-Endoscopic Mucosal Improvement; SES-CD = Simple Endoscopic Score for Crohn's Disease; CDAI = Crohn's Disease Activity Index; PRO2 = 2-item Patient-Reported Outcome_____________________ Reinisch, W., Stepek, D., Kempinski, R., Danese, S., Sands, B.E., Ratiu-Duma, B., Singh, R., Barkay, H., Raphael, G., Jairath, V. (2025, February 19-22). Duvakitug (TEV-48574), an anti-TL1A monoclonal antibody, demonstrates efficacy and favourable safety as an induction treatment in adults with moderately to severely active ulcerative colitis: Results from a phase 2b, randomised, double-blind, placebo-controlled, dose-ranging, basket trial (RELIEVE UCCD) [Presentation OP40]. ECCO 2025, Berlin, Germany. A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease. Accessed February 2025. A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD) Accessed February 2025. Jairath, V., Kierkuś, J., Duvall, G.A., Danese, S. Sands, B.E., Ratiu-Duma, B., Singh, R., Barkay, H., Raphael, G., Reinisch, W. (2025, February 19-22). Duvakitug (TEV-48574), an anti-TL1a monoclonal antibody, demonstrates efficacy and favourable safety as an induction treatment in adults with moderately to severely active Crohn's disease: results from a phase 2b, randomised, double-blind, placebo-controlled dose-ranging, basket trial (RELIEVE UCCD) [Presentation OP41]. ECCO 2025, Berlin, Germany. Inflammatory Bowel Disease (IBD) Basics. Centers for Disease Control and Prevention. 2022. Available at: Accessed February 2025. Ulcerative Colitis Basics. Centers for Disease Control and Prevention. 2024. Accessed February 2025. McDowell, C., Farooq, U., & Haseeb, M. (2020). Inflammatory Bowel Disease (IBD). PubMed; StatPearls Publishing. Accessed February 2025. Clarke AW, et al. MAbs 2018;10(4):664-677. 2. Angeles T, et al. in to access your portfolio
Yahoo
24-02-2025
- Health
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OSE Immunotherapeutics Reports Full Phase 2 Induction Results for Anti-IL-7R mAb Lusvertikimab in Ulcerative Colitis at the 20th Congress of ECCO
OSE Immunotherapeutics Reports Full Phase 2 Induction Results for Anti-IL-7R mAb Lusvertikimab in Ulcerative Colitis at the 20th Congress of ECCO Lusvertikimab achieved statistical significance on the primary and secondary endpoints in moderate to severe active ulcerative colitis (UC) patients during the 10-week induction period of treatment in the randomized, double-blind CoTikiS Phase 2 study. These results were presented in the Top 10 congress highlights oral plenary session at ECCO 2025. Lusvertikimab demonstrated high rates of clinical and endoscopic remission after 10 weeks of treatment, along with clinically meaningful histological improvement and Histo-Endoscopic Mucosal Improvement (HEMI) rates. Treatment with Lusvertikimab significantly reduced fecal calprotectin (FCP) after 10 weeks of treatment, an objective biomarker of mucosal inflammation in UC patients and an early predictor of endoscopic and histological responses. Statistically significant efficacy was demonstrated in clinical and endoscopic remission in the UC patient subgroup with high baseline FCP (>250µg/g). A good safety and tolerability profile was observed with no clinically relevant safety signals. NANTES, France – February 24, 2025, 7:30am CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), presented full efficacy and safety data from the induction period of the randomized, double-blind, placebo-controlled, Phase 2 CoTikiS study of Lusvertikimab (OSE-127) in the Oral and Poster presentations at the 20th Congress of ECCO (European Crohn's and Colitis Organisation), demonstrating meaningful efficacy and a favorable safety profile in moderate to severe active UC patients. Pr. Arnaud Bourreille, Associate Professor in Gastroenterology at the Institut des Maladies de l'Appareil Digestif, Nantes University Hospital, and Coordinating Investigator of the CoTikiS study, said: 'These full Phase 2 clinical induction results provide strong efficacy data for Lusvertikimab in UC, particularly highlighting the meaningful achievement in the key endpoints of endoscopic remission and histological improvement after only 10 weeks of treatment. The latest data showing high histo-endoscopic mucosal improvement (HEMI) and mucosal healing rates represent a strong signal of efficacy, as they are associated with the prediction of long-term prevention of future relapse and are important for UC patients in need of breakthrough therapeutic options and sustained healing.' Pr. Walter Reinisch, Director of the IBD Study Group at the Medical University of Vienna, Department of Internal Medicine, Vienna, Austria, commented: 'Lusvertikimab has been shown to significantly decrease FCP, an objective inflammatory biomarker most commonly used in clinical practice to monitor treatment response in patients with ulcerative colitis. These data parallel and confirm the overall results of the primary and secondary endpoints from the CoTikiS study, highlighting the potential of Lusvertikimab as an efficacious therapy for all UC patients, also by normalising increased baseline FCP values.' Week-10 Induction Period Results in the Global Population1 The randomized, double-blind Phase 2 clinical trial CoTikiS evaluated the efficacy and safety of Lusvertikimab versus placebo in 136 patients with moderate to severe active UC who failed or lost response to previous treatment(s)2. CoTikiS is a 50-week study, with a 10-week induction period evaluating two doses (450 mg or 850 mg) of Lusvertikimab against placebo, a 24-week open-label extension period (OLE) during which subjects received Lusvertikimab 850 mg infusions every four weeks and a 16-week safety follow-up period free of treatment. The induction data at week 10 in the full population and in the subgroup of severe UC patients with high baseline FCP were presented at ECCO 2025. The overall induction results from the CoTikiS study show that the two doses evaluated, 450 mg and 850 mg, met the primary efficacy endpoint (Modified Mayo Score) at week 10 and demonstrated statistically significant and clinically meaningful results on secondary endpoints: Primary End Point at Week 103 Improvement of the Global Disease Activity Index of UC (Modified Mayo Score) Lusv 450mg group: difference of -1.16 point versus placebo (p= 0.019) Lusv 850mg group: difference of -0.9 point versus placebo (p=0.036) 450 + 850mg pooled group: difference of -1.00 point versus placebo (p= 0.010) Secondary Endpoints at Week 10, included: Clinical remission rate: 16% for the pooled 450+850 mg group (n=85) versus 4% for placebo (n=49) (Odds ratio = 4.25; p=0.066) Endoscopic improvement rate: 32% for the pooled group versus 13% for placebo (Odds ratio = 3.29; p=0.027) Endoscopic remission rate: 25% for the pooled group versus 13% for placebo (Odds ratio = 2.33; p=0.120) Ulcerative Colitis Endoscopic Index of Severity (UCEIS) mean score change: -1.35 for the pooled group versus -0.32 for placebo (p=0.007) Fecal Calprotectin (FCP): +189 µg/g for the placebo group, -830 µg/g for the 450mg group (p = 0.009), -635 µg/g for the 850mg group (p=0.018), and -716 μg/g for the pooled group (p=0.004) Exploratory objectives included histological score analysis (centralized and blinded), such as the number and proportion of patients with histological improvement at Week 10, defined by a Nancy Histological Index (NHI) score of 0 or 1, and the number and proportion of patients with histo-endoscopic mucosal improvement at week 10, defined by a NHI ≤ 1 with a Mayo Endoscopic score ≤ 1. Additional histological readouts included Robarts' histological index (RHI) and Geboes score (GS) changes from baseline. Histological Improvement (NHI score ≤ 1) at W10: Chi-square p < 0.01 45.2% in the 450 mg group (n=31); difference versus placebo of 35.2% (p<0.01) 31.0% in the 850 mg group (n=42); difference versus placebo of 21.0% (p=0.02) 37.0% in the 450 + 850 mg pooled group (n=73); difference versus placebo of 27.0% (p<0.01) 10.0% in the placebo group (n=40) Histo-Endoscopic Mucosal Improvement (HEMI) (NHI score ≤ 1 + MES ≤ 1) at W10: Chi-square p = 0.02 32.3% in the 450 mg group; difference versus placebo of 24.8% (p<0.01) 14.3% in the 850 mg group; difference versus placebo of 6.8% (p=0.33) 21.9% in the 450+850 mg pooled group; difference versus placebo of 14.4% (p=0.05) 7.5% in the placebo group Histological Geboes score (GS) mean changes from baseline at W10: Chi-square p = 0.05 450 mg group: -2.9 (SD: 7.2) 850 mg group: -4.2 (SD: 6.1; p<0.01 versus placebo) 450+850 mg pooled group: -3.7 (SD: 6.6; p=0.02 versus placebo) Placebo: -0.7 (SD: 5.1) Histological Robarts Index (RHI) mean changes from baseline at W10: Chi-square p < 0.01 450 mg group: -3.5 (SD: 12.3) 850 mg group: -8.5 (SD: 10.8; p<0.01 versus placebo) 450+850 mg pooled group: -6.4 (SD: 11.7; p=0.01 versus placebo) Placebo: -0.6 (SD: 9.2) Week-10 Induction Results in Severe Active UC with High Baseline Fecal Calprotectin Fecal calprotectin (FCP) is an objective marker of inflammation in UC patients and may predict sustained clinical and endoscopic response. The CoTikiS study included an exploratory endpoint assessing the efficacy of Lusvertikimab 850 mg and 450 mg compared to placebo in patients with FCP > 250 μg/g at baseline, considered the threshold for active and severe inflammatory UC disease. High baseline FCP (> 250 μg/g) represented 69.5% (n=93) of the total Phase 2 population. Baseline FCP was not different between treatment groups. These additional analyses have shown that Lusvertikimab significantly decreased FCP after 10 weeks of treatment in both dose groups and achieved improvements in clinical and endoscopic outcomes in this UC patient population with active inflammation. These data strengthen the overall results of the primary and key secondary endpoints from the CoTikiS study. Fecal Calprotectin (FCP) decreases at W10 450 mg group: difference of -1 169 μg/g versus placebo (p=0.025) 850 mg group: difference of -966 μg/g versus placebo (p=0.034) 450+850 mg pooled group: difference of -1 048 μg/g versus placebo (p=0.011) Fecal Calprotectin (FCP) normalization to below 250 µg/g at W10 38% in the 450 mg group (n=22); difference versus placebo of 20% (p=0.1) 45% in the 850 mg group (n=33); difference versus placebo of 27% (p=0.02) 42% in the 450+850 mg pooled group (n=55); difference versus placebo of 24% (p=0.02) 18% in the placebo group (n=38) Improvement of the Global Disease Activity Index of UC (MMS) 450 mg group; difference of -1.47 point versus placebo (p= 0.011) 850 mg group; difference of -0.95 point versus placebo (p=0.055) 450 + 850 mg pooled group; difference of -1.16 point versus placebo (p= 0.009) Clinical Remission rate at W10: Fisher-test p < 0.01 28.3% in the 450 mg group; difference versus placebo of 28.3% 9.4% in the 850 mg group; difference versus placebo of 9.4% 16.9% in the 450+850 mg pooled group; difference versus placebo of 16.9% 0% in the placebo group Endoscopic Remission rate at W10 38% in the 450 mg group; difference versus placebo of 30.5% (p= 0.03) 14% in the 850 mg group; difference versus placebo of 6.7% (p= 0.33) 24% in the 450+850 mg pooled group; difference versus placebo of 16.3% (p= 0.11) 7% in the Placebo group Ulcerative Colitis Endoscopic Index of Severity (UCEIS) mean score change from baseline 450 mg group; difference of -1.69 point versus placebo (p= 0.003) 850 mg group; difference of -0.74 point versus placebo (p=0.12) 450+850 mg pooled group; difference of -1.12 point versus placebo (p= 0.01) Safety Profile Lusvertikimab displayed a good safety profile and was well tolerated, with no difference between both dose groups and placebo in the incidence of drug-related serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, drug-related AE and severe drug-related AEs, opportunistic infections, or infusion reactions during the induction period. ABOUT ULCERATIVE COLITIS (UC)Ulcerative colitis is a chronic disease of the large intestine, or colon, and rectum, in which the lining of the gastrointestinal tract becomes inflamed and develops ulcers. This condition is the result of an overactive immune system. UC affects 3.3 million patients in the US, Europe and Japan (1). Despite broad therapeutic options, remission rates are only 25-30%, (2) leaving most patients without satisfactory treatments. 15% of patients (3) fail to respond to all therapies and undergo surgery as a last option. (1) EvaluatePharma (2) Drugs Context. 2019; 8: 212572 –doi: 10.7573/dic.212572 (3) Scientific Reports volume 10, Article number: 12546 (2020)ABOUT OSE IMMUNOTHERAPEUTICS OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext. Additional information about OSE Immunotherapeutics assets is available on the Company's website: Click and follow us on X and LinkedInContacts Fiona Dé France Media Contact FP2COMFlorence Portejoiefportejoie@ 6 07 768 283U.S. Media ContactRooney Partners LLCKate Barrettekbarrette@ 212 223 0561 Forward-looking statementsThis press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics' management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as 'expect', 'anticipate', 'believe', 'target', 'plan', or 'estimate', their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics' shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2024, including the annual financial report for the fiscal year 2023, available on the OSE Immunotherapeutics' website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. 1 An interim futility analysis performed early (approx. 30% of patients) by the IDMC proposed stopping the 450 mg group due to the risk of futility. The 850 mg group was initially considered as the primary analysis; however, in the final analysis, the futility of the 450mg dose group was not confirmed. Statistical Analysis Plan (SAP) Addendum: results of 450mg group of patients were included in the analyses. In addition, the two groups were pooled for the active drug cohort to evaluate a global treatment effect. 2 Previous corticosteroids, immunosuppressive agents or previous biological treatments.3 OSE Immunotherapeutics Press Release of November 4th 2024: EN_241104_Lusvertikimab Attachment EN_250224_ECCO Clinical presentation_FINAL
Associated Press
22-02-2025
- Health
- Associated Press
Press Release: ECCO 2025: new duvakitug data reinforce best-in-class potential in ulcerative colitis and Crohn's disease
ECCO 2025: new duvakitug data reinforce best-in-class potential in ulcerative colitis and Crohn's disease New detailed data from the RELIEVE UCCD study support overall efficacy and safety of duvakitug in all pre-specified subgroups across the different doses New endpoints presented include findings on clinical and endoscopic outcomes and histological-endoscopic mucosal improvement Findings to form the basis for a phase 3 program, anticipated to start in H2 2025 Paris and Parsippany, NJ, February 22, 2025. Sanofi and Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd., today presented new, detailed results from the RELIEVE UCCD phase 2b study of duvakitug, a human IgG1-λ2 monoclonal antibody targeting TL1A, in patients with moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD), the two most common forms of inflammatory bowel disease (IBD). These results were shared in two oral presentations at the 20th Congress of the European Crohn's and Colitis Organisation (ECCO) in Berlin, Germany. Ulcerative colitis In the UC cohort of the RELIEVE UCCD study, 36% (450 mg dose) and 48% (900 mg dose) of patients treated with duvakitug achieved the primary endpoint of clinical remission (mMS)* at week 14 compared to 20% treated with placebo; placebo-adjusted rates were 16% (450 mg dose) and 27% (900 mg dose) (p=0.050 and 0.003, respectively). In addition, higher clinical remission rates were observed for both doses of duvakitug versus placebo in both advanced therapy (AT) -experienced and AT-naïve subgroups of patients. AT-experienced: 29% (450 mg) and 36% (900 mg), with placebo-adjusted rates of 22% (450 mg) and 29% (900 mg). AT-naïve: 39% (450 mg) and 53% (900 mg), with placebo-adjusted rates of 12% (450 mg) and 26% (900 mg). Additional endpoints observed*: Clinical response (mMS): 81% (450 mg) and 70% (900 mg) compared to 52% treated with placebo. Endoscopic improvement (MES): 45% (450 mg) and 50% (900 mg) compared to 23% treated with placebo. Histological-endoscopic mucosal improvement (HEMI): 30% (450 mg) and 33% (900 mg) compared to 16% treated with placebo. Walter Reinisch, MD, PhD, Medical University of Vienna, and lead investigator of the RELIEVE UCCD study 'Patients, many of whom have spent years in a recurring cycle of remission and relapse, have been waiting a long time for better options in treating ulcerative colitis. We're highly encouraged by the significant treatment response, compared to placebo, seen in the study, both in advanced therapy naïve-and experienced patients,' said Walter Reinisch, MD, PhD, Medical University of Vienna, and lead investigator of the RELIEVE UCCD study. 'With this potential of duvakitug to reduce inflammation, we could truly transform treatment for patients with IBD in a safe manner.' Crohn's disease In the CD cohort of the RELIEVE UCCD study, 26% (450 mg dose) and 48% (900 mg dose) of patients treated with duvakitug achieved the primary endpoint of endoscopic response (SES-CD)* compared to 13% on placebo; placebo-adjusted rates were 13% (450 mg dose) and 35% (900 mg dose) at week 14 (p= 0.058 and <0.001, respectively). In addition, higher endoscopic response rates were observed for both doses of duvakitug versus placebo in both AT-experienced and AT-naïve subgroups of patients. AT-experienced: 11% (450 mg) and 48% (900 mg), with placebo-adjusted rates of 7% (450 mg) and 44% (900 mg). AT-naïve: 47% (450 mg) and 47% (900 mg), with placebo-adjusted rates of 25% (450 mg) and 25% (900 mg). Additional endpoints observed*: Endoscopic remission (SES-CD): 17% (450 mg) and 26% (900 mg) compared to 9% treated with placebo. Clinical remission (CDAI): 50% (450 mg) and 54% (900 mg) compared to 41% treated with placebo. Clinical response (CDAI): 61% (450 mg) and 62% (900 mg) compared to 41% treated with placebo. Clinical response (PRO2): 50% (450 mg) and 53% (900 mg) compared to 29% treated with placebo. Vipul Jairath, MBChB, DPhil, FRCP, FRCPC Professor of Medicine in the Departments of Medicine, Epidemiology and Biostatistics at Western University, and lead investigator of the RELIEVE UCCD study 'Every day, I see patients with Crohn's disease who continue to suffer from the often-severe symptoms of the disease despite available treatments,' said Vipul Jairath, MBChB, DPhil, FRCP, FRCPC, Professor of Medicine in the Departments of Medicine, Epidemiology and Biostatistics at Western University, and lead investigator of the RELIEVE UCCD study. 'The endoscopic response rates seen in this study support the potential of duvakitug as an effective new option for those who are in desperate need of relief.' RELIEVE UCCD safety data summary In both the UC and CD cohorts, duvakitug was generally well tolerated with no emergent safety signals observed. No dose-dependent or adverse event (AE) pattern was observed for treatment-related AEs, serious adverse events (SAEs), AEs leading to discontinuation or adverse events of special interest (AESIs). Duvakitug is currently under clinical investigation, and its efficacy and safety have not been evaluated by any regulatory authority. About inflammatory bowel disease UC and CD, the two main types of IBD, are chronic inflammatory conditions of the gastrointestinal (GI) tract resulting in debilitating and persistent symptoms such as abdominal pain, diarrhea, rectal bleeding, fatigue and weight loss. Prolonged inflammation can lead to damage within the GI tract, including fibrosis, a common complication of IBD characterized by an accumulation of scar tissue in the intestinal wall, which may cause narrowing and obstruction often requiring hospitalization and surgery. There is currently no cure for IBD – the goal of treatment is to induce and maintain remission and prevent flares. RELIEVE UCCD was a 14-week phase 2b, randomized, double-blinded, dose-ranging study to determine the efficacy, safety, pharmacokinetics, and tolerability of duvakitug in adults with moderate-to-severe UC or CD. The study was an innovative and efficient basket study design allowing the inclusion of patients with either type UC and CD. It is also the first and only randomized, blinded and placebo-controlled phase 2 study to investigate the impact of TL1A in CD. In the study, patients who met pre-specified inclusion criteria were randomized to receive one of two duvakitug doses or placebo, administered every two weeks subcutaneously, in a 1:1:1 ratio for each indication (UC or CD) stratified by previous exposure to advanced IBD therapies for 14 weeks. The UC cohort comprised adults with moderately to severely active disease with inadequate response, loss of response or intolerance to previous conventional and/or advanced therapies (AT). The CD cohort comprised adults with moderately to severely active disease with documented inadequate response, loss of response or intolerance to conventional and/or ATs. Primary efficacy endpoints are the number of participants who showed clinical remission (as defined by the modified Mayo score) in the UC cohort or the number of participants who showed endoscopic response (as defined by the SES-CD endoscopic score for CD) in the CD cohort. The study included sites in the US, Europe, Israel, and Asia. About duvakitug Duvakitug is a potential best-in-class human IgG1-λ2 monoclonal antibody that targets tumor necrosis factor (TNF)-like ligand 1A (TL1A), also known as TNF superfamily member 15 (TNFSF15). TL1A signaling is believed to amplify inflammation and drive fibrosis associated with IBD through binding its receptor, death receptor 3 (DR3). Duvakitug is uniquely designed to inhibit preferentially TL1A signaling via DR3, with the potential advantage of reduced TL1A-DcR3 inhibition. Duvakitug is currently in a phase 2b clinical study for the treatment of UC and CD, the two most common types of IBD. The safety and efficacy of duvakitug have not been reviewed by any regulatory authority. About the Teva and Sanofi collaboration Teva and Sanofi are collaborating to co-develop and co-commercialize Teva's duvakitug for the treatment of UC and CD. Each company will equally share the development costs globally, and the net profits and losses in major markets, with other markets subject to a royalty arrangement. Sanofi will lead the phase 3 clinical development program. Teva will lead commercialization of the product in Europe, Israel and specified other countries, and Sanofi will lead commercialization in North America, Japan, other parts of Asia and the rest of the world. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global pharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company's global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. If patients have a need, we're already working to address it. To learn more about how Teva is all in for better health, visit About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media Relations Sandrine Guendoul | +33 6 25 09 14 25 | [email protected] Evan Berland | +1 215 432 0234 | [email protected] Nicolas Obrist | +33 6 77 21 27 55 | [email protected] Léo Le Bourhis | +33 6 75 06 43 81 | [email protected] Victor Rouault | +33 6 70 93 71 40 | [email protected] Timothy Gilbert | +1 516 521 2929 | [email protected] Investor Relations Thomas Kudsk Larsen |+44 7545 513 693 | [email protected] Alizé Kaisserian | +33 6 47 04 12 11 | [email protected] Felix Lauscher | +1 908 612 7239 | [email protected] Keita Browne | +1 781 249 1766 | [email protected] Nathalie Pham | +33 7 85 93 30 17 | [email protected] Tarik Elgoutni | + 1 617 710 3587 | [email protected] Thibaud Châtelet | + 33 6 80 80 89 90 | [email protected] Sanofi forward-looking statement This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words 'expects', 'anticipates', 'believes', 'intends', 'estimates', 'plans' and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under 'Risk Factors' and 'Cautionary Statement Regarding Forward-Looking Statements' in Sanofi's annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group. Teva Cautionary note regarding forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as 'should,' 'expect,' 'anticipate,' 'estimate,' 'target,' 'may,' 'project,' 'guidance,' 'intend,' 'plan,' 'believe' and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop duvakitug for the treatment of ulcerative colitis (UC) and Crohn's disease (CD); our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generic medicines; the effectiveness of our patents and other measures to protect our intellectual property rights; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2024, and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the section captioned 'Risk Factors.' Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. *P-values reported are one-sided at a significance level of 0.10.
Yahoo
22-02-2025
- Health
- Yahoo
Press Release: ECCO 2025: new duvakitug data reinforce best-in-class potential in ulcerative colitis and Crohn's disease
ECCO 2025: new duvakitug data reinforce best-in-class potential in ulcerative colitis and Crohn's disease New detailed data from the RELIEVE UCCD study support overall efficacy and safety of duvakitug in all pre-specified subgroups across the different doses New endpoints presented include findings on clinical and endoscopic outcomes and histological-endoscopic mucosal improvement Findings to form the basis for a phase 3 program, anticipated to start in H2 2025 Paris and Parsippany, NJ, February 22, 2025. Sanofi and Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd., today presented new, detailed results from the RELIEVE UCCD phase 2b study of duvakitug, a human IgG1-λ2 monoclonal antibody targeting TL1A, in patients with moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD), the two most common forms of inflammatory bowel disease (IBD). These results were shared in two oral presentations at the 20th Congress of the European Crohn's and Colitis Organisation (ECCO) in Berlin, Germany. Ulcerative colitis In the UC cohort of the RELIEVE UCCD study, 36% (450 mg dose) and 48% (900 mg dose) of patients treated with duvakitug achieved the primary endpoint of clinical remission (mMS)* at week 14 compared to 20% treated with placebo; placebo-adjusted rates were 16% (450 mg dose) and 27% (900 mg dose) (p=0.050 and 0.003, respectively). In addition, higher clinical remission rates were observed for both doses of duvakitug versus placebo in both advanced therapy (AT) -experienced and AT-naïve subgroups of patients. AT-experienced: 29% (450 mg) and 36% (900 mg), with placebo-adjusted rates of 22% (450 mg) and 29% (900 mg). AT-naïve: 39% (450 mg) and 53% (900 mg), with placebo-adjusted rates of 12% (450 mg) and 26% (900 mg). Additional endpoints observed*: Clinical response (mMS): 81% (450 mg) and 70% (900 mg) compared to 52% treated with placebo. Endoscopic improvement (MES): 45% (450 mg) and 50% (900 mg) compared to 23% treated with placebo. Histological-endoscopic mucosal improvement (HEMI): 30% (450 mg) and 33% (900 mg) compared to 16% treated with placebo. Medical University of Vienna, and lead investigator of the RELIEVE UCCD study 'Patients, many of whom have spent years in a recurring cycle of remission and relapse, have been waiting a long time for better options in treating ulcerative colitis. We're highly encouraged by the significant treatment response, compared to placebo, seen in the study, both in advanced therapy naïve-and experienced patients,' said Walter Reinisch, MD, PhD, Medical University of Vienna, and lead investigator of the RELIEVE UCCD study. 'With this potential of duvakitug to reduce inflammation, we could truly transform treatment for patients with IBD in a safe manner.' Crohn's diseaseIn the CD cohort of the RELIEVE UCCD study, 26% (450 mg dose) and 48% (900 mg dose) of patients treated with duvakitug achieved the primary endpoint of endoscopic response (SES-CD)* compared to 13% on placebo; placebo-adjusted rates were 13% (450 mg dose) and 35% (900 mg dose) at week 14 (p= 0.058 and <0.001, respectively). In addition, higher endoscopic response rates were observed for both doses of duvakitug versus placebo in both AT-experienced and AT-naïve subgroups of patients. AT-experienced: 11% (450 mg) and 48% (900 mg), with placebo-adjusted rates of 7% (450 mg) and 44% (900 mg). AT-naïve: 47% (450 mg) and 47% (900 mg), with placebo-adjusted rates of 25% (450 mg) and 25% (900 mg). Additional endpoints observed*: Endoscopic remission (SES-CD): 17% (450 mg) and 26% (900 mg) compared to 9% treated with placebo. Clinical remission (CDAI): 50% (450 mg) and 54% (900 mg) compared to 41% treated with placebo. Clinical response (CDAI): 61% (450 mg) and 62% (900 mg) compared to 41% treated with placebo. Clinical response (PRO2): 50% (450 mg) and 53% (900 mg) compared to 29% treated with placebo. Professor of Medicine in the Departments of Medicine, Epidemiology and Biostatistics at Western University, and lead investigator of the RELIEVE UCCD study 'Every day, I see patients with Crohn's disease who continue to suffer from the often-severe symptoms of the disease despite available treatments,' said Vipul Jairath, MBChB, DPhil, FRCP, FRCPC, Professor of Medicine in the Departments of Medicine, Epidemiology and Biostatistics at Western University, and lead investigator of the RELIEVE UCCD study. 'The endoscopic response rates seen in this study support the potential of duvakitug as an effective new option for those who are in desperate need of relief.' RELIEVE UCCD safety data summaryIn both the UC and CD cohorts, duvakitug was generally well tolerated with no emergent safety signals observed. No dose-dependent or adverse event (AE) pattern was observed for treatment-related AEs, serious adverse events (SAEs), AEs leading to discontinuation or adverse events of special interest (AESIs). Duvakitug is currently under clinical investigation, and its efficacy and safety have not been evaluated by any regulatory authority. About inflammatory bowel disease UC and CD, the two main types of IBD, are chronic inflammatory conditions of the gastrointestinal (GI) tract resulting in debilitating and persistent symptoms such as abdominal pain, diarrhea, rectal bleeding, fatigue and weight loss. Prolonged inflammation can lead to damage within the GI tract, including fibrosis, a common complication of IBD characterized by an accumulation of scar tissue in the intestinal wall, which may cause narrowing and obstruction often requiring hospitalization and surgery. There is currently no cure for IBD – the goal of treatment is to induce and maintain remission and prevent flares. About the RELIEVE UCCD phase 2b studyRELIEVE UCCD was a 14-week phase 2b, randomized, double-blinded, dose-ranging study to determine the efficacy, safety, pharmacokinetics, and tolerability of duvakitug in adults with moderate-to-severe UC or CD. The study was an innovative and efficient basket study design allowing the inclusion of patients with either type UC and CD. It is also the first and only randomized, blinded and placebo-controlled phase 2 study to investigate the impact of TL1A in CD. In the study, patients who met pre-specified inclusion criteria were randomized to receive one of two duvakitug doses or placebo, administered every two weeks subcutaneously, in a 1:1:1 ratio for each indication (UC or CD) stratified by previous exposure to advanced IBD therapies for 14 weeks. The UC cohort comprised adults with moderately to severely active disease with inadequate response, loss of response or intolerance to previous conventional and/or advanced therapies (AT). The CD cohort comprised adults with moderately to severely active disease with documented inadequate response, loss of response or intolerance to conventional and/or ATs. Primary efficacy endpoints are the number of participants who showed clinical remission (as defined by the modified Mayo score) in the UC cohort or the number of participants who showed endoscopic response (as defined by the SES-CD endoscopic score for CD) in the CD cohort. The study included sites in the US, Europe, Israel, and Asia. About duvakitugDuvakitug is a potential best-in-class human IgG1-λ2 monoclonal antibody that targets tumor necrosis factor (TNF)-like ligand 1A (TL1A), also known as TNF superfamily member 15 (TNFSF15). TL1A signaling is believed to amplify inflammation and drive fibrosis associated with IBD through binding its receptor, death receptor 3 (DR3). Duvakitug is uniquely designed to inhibit preferentially TL1A signaling via DR3, with the potential advantage of reduced TL1A-DcR3 inhibition. Duvakitug is currently in a phase 2b clinical study for the treatment of UC and CD, the two most common types of IBD. The safety and efficacy of duvakitug have not been reviewed by any regulatory authority. About the Teva and Sanofi collaborationTeva and Sanofi are collaborating to co-develop and co-commercialize Teva's duvakitug for the treatment of UC and CD. Each company will equally share the development costs globally, and the net profits and losses in major markets, with other markets subject to a royalty arrangement. Sanofi will lead the phase 3 clinical development program. Teva will lead commercialization of the product in Europe, Israel and specified other countries, and Sanofi will lead commercialization in North America, Japan, other parts of Asia and the rest of the world. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global pharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company's global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. If patients have a need, we're already working to address it. To learn more about how Teva is all in for better health, visit About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | +33 6 25 09 14 25 | Evan Berland | +1 215 432 0234 | Nicolas Obrist | +33 6 77 21 27 55 | Léo Le Bourhis | +33 6 75 06 43 81 | Victor Rouault | +33 6 70 93 71 40 | Gilbert | +1 516 521 2929 | Investor RelationsThomas Kudsk Larsen |+44 7545 513 693 | Alizé Kaisserian | +33 6 47 04 12 11 | Lauscher | +1 908 612 7239 | Keita Browne | +1 781 249 1766 | Pham | +33 7 85 93 30 17 | Elgoutni | + 1 617 710 3587 | Thibaud Châtelet | + 33 6 80 80 89 90 | Teva Media Relations TevaCommunicationsNorthAmerica@ Teva Investor Relations TevaIR@ Sanofi forward-looking statement This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words 'expects', 'anticipates', 'believes', 'intends', 'estimates', 'plans' and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under 'Risk Factors' and 'Cautionary Statement Regarding Forward-Looking Statements' in Sanofi's annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group. Teva Cautionary note regarding forward-looking statementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as 'should,' 'expect,' 'anticipate,' 'estimate,' 'target,' 'may,' 'project,' 'guidance,' 'intend,' 'plan,' 'believe' and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop duvakitug for the treatment of ulcerative colitis (UC) and Crohn's disease (CD); our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generic medicines; the effectiveness of our patents and other measures to protect our intellectual property rights; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2024, and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the section captioned 'Risk Factors.' Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. *P-values reported are one-sided at a significance level of 0.10. mMS = modified Mayo Score; MES = Mayo Endoscopic Subscore; HEMI = Histological-Endoscopic Mucosal Improvement; SES-CD = Simple Endoscopic Score for Crohn's Disease; CDAI = Crohn's Disease Activity Index; PRO2 = 2-item Patient-Reported Outcome _____________________Attachment Press Release
