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 www.tevapharm.com.
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 | sandrine.guendoul@sanofi.com Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com Nicolas Obrist | +33 6 77 21 27 55 | nicolas.obrist@sanofi.com Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.comTimothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Investor RelationsThomas Kudsk Larsen |+44 7545 513 693 | thomas.larsen@sanofi.com Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.comFelix Lauscher | +1 908 612 7239 | felix.lauscher@sanofi.com Keita Browne | +1 781 249 1766 | keita.browne@sanofi.comNathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.comTarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Teva Media Relations TevaCommunicationsNorthAmerica@tevapharm.com
Teva Investor Relations TevaIR@tevapharm.com
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
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
15 hours ago
- Yahoo
6 toilet habit changes you should always see a doctor about
No one enjoys talking about bowel movements. But ignoring the signs your body is trying to send you can mean putting off a diagnosis you really need to hear. Just ask TOWIE star Chloe Meadows. The reality TV regular recently shared on Dr Oscar Duke's Bedside Manners podcast that she'd spent a decade silently struggling with bleeding, stomach pain and extreme fatigue before finally getting a diagnosis: ulcerative colitis, a chronic condition that causes inflammation and ulcers in the colon. She lived with on-and-off symptoms for years, assuming they'd passed. It wasn't until age 26, when she became visibly unwell, that a blood test led her to A&E and finally, a diagnosis. Meadows' experience is an important reminder that when your toilet habits change – and stay changed – it's time to talk to your GP. Below, we break down six toilet-related red flags that experts say you should never ignore. And no, it's not just about your bowel movements; your wee, urgency levels, and even smells all matter, too. Whether you're suddenly constipated, dealing with constant diarrhoea, or noticing your stool looks different (narrower, paler or greasy), changes that last longer than a few weeks are worth investigating. The NHS advises that ongoing shifts in bowel habits could be linked to anything from diet and stress to Irritable Bowel Syndrome (IBS), coeliac disease or inflammatory bowel disease (IBD). In some cases, persistent symptoms could be a sign of bowel cancer, so don't brush them off. When to see your GP: If your usual routine has changed for more than two to three weeks, especially if it's paired with stomach pain, fatigue, or weight loss. It might be bright red or dark and tarry; either way, it's not something to ignore. Bright red blood can come from piles or small tears, but darker blood might mean there's bleeding higher up in the digestive system. When to see your GP: If you see blood in your poo. You may be offered a stool test, or in some cases, a referral for further checks. If anything feels amiss and suddenly starts to sting, burn or feel uncomfortable, you might assume it's a urinary tract infection (UTI). And often, that's true. But it can also be a sign of kidney stones or bladder issues. Blood in your urine should also be taken seriously, even if it only happens once. When to see your GP: If you have pain while urinating, see blood or feel the urge to go far more often than usual. Needing the loo more often than usual (especially at night), feeling like you can't wait, or leaking a little when you cough, sneeze or laugh could signal an overactive bladder, prostate issues (in men), or pelvic floor dysfunction. These symptoms might feel embarrassing, but they're generally common and manageable with the right support. When to see your GP: If bladder leaks or urgency interfere with your daily life, or if you notice a sudden change in how often you need to go. A little mucus in your stool isn't always a worry, but frequent slimy stools can be a sign of infection or inflammation in your gut. When to see your GP: If mucus appears regularly, especially if it comes with bloating, pain or a change in bowel movements. If going to the toilet has become uncomfortable, painful, or feels like hard work, that's your body waving a red flag. Regular straining can cause or worsen hemorrhoids, but it might also signal bowel issues or even neurological problems affecting your pelvic floor. When to see your GP: If you're straining often, feel like you're not fully emptying your bowels, or notice pain during or after a bowel movement. If you're unsure, remember that everyone has their own baseline of what's 'normal'. However, there are a few simple signs to watch for as a guide. According to the Bladder and Bowel Health Service, healthy bowel movements should be soft, smooth and easy to pass; ideally at least three times a week. You should also be able to urinate without pain or discomfort. If you also notice you're often bloated, tired, straining, or notice blood or mucus, it's time to speak to your GP. Changes might be harmless, but they're always worth checking. Read more on bowel habits: This Poop Chart Will Tell You If Your Bathroom Habits Are Actually Healthy Or If You Need To See A Doctor ASAP (Buzzfeed, 4-min read) How 'blowing bubbles' and 'mooing' can help ease constipation, according to NHS doctor (Yahoo Life UK, 4-min read) Bowel cancer cases in young people rising sharply in England, study finds (PA Media, 4-min read)
Yahoo
3 days ago
- Yahoo
Health New England to replace Humira coverage with lower-cost biosimilars
SPRINGFIELD, Mass. (WWLP) – Health New England announced Monday that it will shift coverage of the biologic drug Humira to more affordable FDA-approved biosimilars starting next month for members of its commercial health plans. Markey playing defense against GOP clean energy plans Effective July 1, the not-for-profit health insurer will cover Amjevita by Nuvaila and Hadlima instead of Humira, as part of a broader effort to manage rising health care costs while maintaining access to effective treatments. Humira is used to treat several chronic inflammatory conditions, including rheumatoid arthritis, Crohn's disease, and plaque psoriasis. 'Biologic medications like Humira are complex treatments that carry significant cost. Its biosimilars provide a meaningful opportunity to enhance affordability for the health care ecosystem while members continue to get the full benefits of the medication,' said Gary Tereso, PharmD, Director of Pharmacy Services at Health New England. Biologic drugs are made from living organisms and are typically more expensive than other medications. Biosimilars are developed to be nearly identical in safety, potency, and efficacy to the original biologic, but at a significantly lower cost. The shift in coverage is intended to make treatment more accessible and financially sustainable for members and employer groups alike. Health New England is directly reaching out to members who are currently prescribed Humira, along with their health care providers and pharmacies, to assist with the transition. The company said it will continue monitoring the biosimilar marketplace to ensure members receive both high-quality care and cost-effective treatment options. WWLP-22News, an NBC affiliate, began broadcasting in March 1953 to provide local news, network, syndicated, and local programming to western Massachusetts. Watch the 22News Digital Edition weekdays at 4 p.m. on Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
6 days ago
- Yahoo
Spyre Therapeutics Announces Grants of Inducement Awards
WALTHAM, Mass., June 6, 2025 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ: SYRE) (the "Company" or "Spyre"), a clinical-stage biotechnology company utilizing best-in-class antibody engineering, dose optimization and rational therapeutic combinations to target improved efficacy and convenience in the treatment of IBD and other immune-mediated diseases, today announced that Spyre's independent Compensation Committee of the Board of Directors approved the grant of stock options to purchase 50,200 shares of common stock of Spyre to three non-executive employees as equity inducement awards under the Spyre Therapeutics, Inc. 2018 Equity Inducement Plan, as amended (the "2018 Plan"). The stock options were approved on June 2, 2025 and were material to each employee's acceptance of employment with Spyre, in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options were granted with a 10-year term and an exercise price equal to $15.40, the closing price per share of Spyre's common stock as reported by Nasdaq on June 2, 2025. The options granted to each employee shall vest and become exercisable as to one-fourth (1/4th) of the shares subject to the respective options on the first anniversary of the employee's start date, and one-forty-eighth (1/48th) of the shares subject to the respective options shall vest and become exercisable monthly thereafter, in each case, subject to continuous service with Spyre through the applicable vesting dates. The stock options are subject to the terms of the 2018 Plan. About Spyre Therapeutics Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. For more information, visit Spyre's website at View original content to download multimedia: SOURCE Spyre Therapeutics, Inc.
