Latest news with #Lusvertikimab
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05-05-2025
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OSE Immunotherapeutics Announces >90% of Responders Maintained Symptomatic Remission Through Extension Period on Lusvertikimab
OSE Immunotherapeutics Announces >90% of Responders Maintained Symptomatic Remission Through Extension Period on Lusvertikimab Lusvertikimab well tolerated over the 24-week additional treatment period. Oral presentation at DDW 2025 of clinical data from the anti-IL-7R mAb Lusvertikimab open-label extension of the phase 2 CoTikiS study in ulcerative colitis.1,2 Full clinical data package for study demonstrates potential of a first-in-class monotherapy with a novel mechanism of action in chronic and inflammatory diseases. NANTES, France – May 5, 2025, 6:30 p.m. CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) announced that over >90% of people living with ulcerative colitis (UC) who achieved a clinical response after 10 weeks of treatment with Lusvertikimab maintained symptomatic remission for an additional 24 weeks. Of the participants who did not reach symptomatic remission in the first 10 weeks of treatment with either dose of Lusvertikimab, 61% had achieved remission after a further 24 weeks on the 850 mg dose. Lusvertikimab was well tolerated over the 24-week extended treatment period.1 These findings from the open-label extension (OLE) of the Phase 2 CoTikiS study of the anti-IL-7 receptor monoclonal antibody Lusvertikimab in UC,2 were presented at Digestive Disease Week in San Diego (May 3 – 6, 2025).1 These build on results from the earlier induction phase presented at the ECCO 2025 congress in February.3 Sonya Montgomery, Chief Development Officer of OSE Immunotherapeutics, commented: 'These new data provide insights into the longer-term benefits and safety of Lusvertikimab in UC, with 89% of patients continuing into the OLE period and 87% completing it. More than 90% of Lusvertikimab patients in symptomatic remission following induction reported a durable response to treatment, and Lusvertikimab also demonstrated very good safety and tolerability over the course of the study, which included 24 weeks on the high dose for all patients. 'We also observed an increase in symptomatic remission rates across groups in the OLE, with the 850 mg induction phase dose group showing this deepening of effect after one additional dose. The OLE data support the potential of Lusvertikimab as a monotherapy with a positive impact on symptom management and patient quality of life.' Arnaud Bourreille, Associate Professor in Gastro-Enterology at CHU Nantes and principal investigator of the study, commented: 'Despite the broad range of approaches to manage ulcerative colitis, remission of symptoms can be hard to reach, with only 25-30% of people typically able to achieve and maintain remission of symptoms on any one treatment.4,5 For people living with ulcerative colitis, these findings are an important step towards challenging this therapeutic ceiling.' Findings from the OLE period, extending from Week 10 to Week 34, complete the CoTikiS dataset which provides a compelling Phase 2 efficacy and safety data package for Lusvertikimab in UC. Sonya Montgomery added: 'The complete CoTikiS results give us confidence in Luservtikimab's novel mechanism of action benefiting ulcerative colitis patients, and its potential in other chronic autoimmune and inflammatory diseases where there is a strong biological rationale. The CoTikiS clinical results support progressing Luzvertikimab's development and brings us closer to our goal of delivering a long-acting therapy designed to treat the underlying disease pathophysiology.' OVERVIEW OF COTIKIS EXTENSION PERIOD (OLE) FINDINGS1 Lusvertikimab demonstrated a deepening of treatment response and durable response, with a high rate of symptomatic remission.1 89% of participants entered the OLE period and 87% of them completed the study. Rates of symptomatic remission6 improved for all dose groups in the OLE period, suggesting a deepening of efficacy. For participants who had received the 850 mg dose from the beginning of the study, rates plateaued already after Week 14; rates of symptomatic remission continued to improve through week 26 for the 450 mg induction group (10 weeks of 450 mg, 16 weeks of 850 mg dosing) and through week 34 for the group receiving placebo in the induction phase (10 weeks of placebo, 14 weeks of 850 mg Lusvertikimab). 92% of participants who had achieved symptomatic remission with either dose of Lusvertikimab in the induction period maintained it through the OLE period7 including 100% of those who achieved remission in the 850 mg dose group. 61% of participants who had not achieved symptomatic remission with either dose of Lusvertikimab in the induction period went on to achieve it during the OLE period. 85% of participants who had been in the placebo arm during the induction period went on to achieve symptomatic remission after receiving 850 mg in the OLE period. 82% of participants achieved remission of rectal bleeding by the end of the OLE. Lusvertikimab was well tolerated over a 34-week treatment period, with a good safety profile and without a higher rate or severity of infection. ABOUT THE COTIKIS STUDY1-3 CoTikiS, a randomized, double-blind, placebo-controlled 50-week clinical study,2 consisted of: A 10-week induction period evaluating two doses (450 mg or 850 mg) of Lusvertikimab versus placebo; A 24-week OLE period in which all participants received Lusvertikimab 850 mg infusions every four weeks; and A 16-week safety follow-up period without treatment. Findings from the induction phase of the CoTikiS study were presented in February at the 2025 ECCO congress. Both doses met the primary efficacy endpoint (improvement in Modified Mayo Score at Week 10) and demonstrated statistically significant and clinically meaningful results on secondary clinical, endoscopy and histology endpoints.3 REFERENCES / FOOTNOTES Bourreille A et al., Oral presentation #913, Digestive Disease Week, 5 May 2025, San Diego, USA. Bourreille A et al., J Crohn's & Colitis 2025; 19(1):i71–i72. doi: 10.1093/ecco-jcc/jjae190.0036. EU Clinical Trials Register: CoTikiS study record (2020-001398-59), available via [Accessed May 2025]. Yanofsky R & Rubin DT, J Can. Assoc. Gastroenterology 2025;8(S2):S6–S14, doi: 10.1093/jcag/gwae058. Le Berre C et al. Lancet 2023;402(10401):571–584, doi: 10.1016/S0140-6736(23)00966-2. Symptomatic remission on Mayo patient-reported outcomes 2, PRO2 (stool frequency subscore + rectal bleeding subscore) = 0 or 1 and rectal bleeding subscore = 0. Responders are defined as patients with endoscopic score of 0 or 1 at Week 10. ABOUT DIGESTIVE DISEASE WEEK (DDW)Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 3-6, 2025. The meeting showcases nearly 6,000 abstracts and over 1,000 invited talks on the latest advances in GI research, medicine and technology. More information can be found at 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: Follow us on LinkedIn. Contacts Fiona Dé French Media Contact FP2COMFlorence Portejoiefportejoie@ 6 07 768 283 U.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, 2025, including the annual financial report for the fiscal year 2024, 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. Attachment EN_250505_DDW Lusvertikimab_FINALSign in to access your portfolio
Yahoo
05-05-2025
- Health
- Yahoo
OSE Immunotherapeutics Announces >90% of Responders Maintained Symptomatic Remission Through Extension Period on Lusvertikimab
OSE Immunotherapeutics Announces >90% of Responders Maintained Symptomatic Remission Through Extension Period on Lusvertikimab Lusvertikimab well tolerated over the 24-week additional treatment period. Oral presentation at DDW 2025 of clinical data from the anti-IL-7R mAb Lusvertikimab open-label extension of the phase 2 CoTikiS study in ulcerative colitis.1,2 Full clinical data package for study demonstrates potential of a first-in-class monotherapy with a novel mechanism of action in chronic and inflammatory diseases. NANTES, France – May 5, 2025, 6:30 p.m. CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) announced that over >90% of people living with ulcerative colitis (UC) who achieved a clinical response after 10 weeks of treatment with Lusvertikimab maintained symptomatic remission for an additional 24 weeks. Of the participants who did not reach symptomatic remission in the first 10 weeks of treatment with either dose of Lusvertikimab, 61% had achieved remission after a further 24 weeks on the 850 mg dose. Lusvertikimab was well tolerated over the 24-week extended treatment period.1 These findings from the open-label extension (OLE) of the Phase 2 CoTikiS study of the anti-IL-7 receptor monoclonal antibody Lusvertikimab in UC,2 were presented at Digestive Disease Week in San Diego (May 3 – 6, 2025).1 These build on results from the earlier induction phase presented at the ECCO 2025 congress in February.3 Sonya Montgomery, Chief Development Officer of OSE Immunotherapeutics, commented: 'These new data provide insights into the longer-term benefits and safety of Lusvertikimab in UC, with 89% of patients continuing into the OLE period and 87% completing it. More than 90% of Lusvertikimab patients in symptomatic remission following induction reported a durable response to treatment, and Lusvertikimab also demonstrated very good safety and tolerability over the course of the study, which included 24 weeks on the high dose for all patients. 'We also observed an increase in symptomatic remission rates across groups in the OLE, with the 850 mg induction phase dose group showing this deepening of effect after one additional dose. The OLE data support the potential of Lusvertikimab as a monotherapy with a positive impact on symptom management and patient quality of life.' Arnaud Bourreille, Associate Professor in Gastro-Enterology at CHU Nantes and principal investigator of the study, commented: 'Despite the broad range of approaches to manage ulcerative colitis, remission of symptoms can be hard to reach, with only 25-30% of people typically able to achieve and maintain remission of symptoms on any one treatment.4,5 For people living with ulcerative colitis, these findings are an important step towards challenging this therapeutic ceiling.' Findings from the OLE period, extending from Week 10 to Week 34, complete the CoTikiS dataset which provides a compelling Phase 2 efficacy and safety data package for Lusvertikimab in UC. Sonya Montgomery added: 'The complete CoTikiS results give us confidence in Luservtikimab's novel mechanism of action benefiting ulcerative colitis patients, and its potential in other chronic autoimmune and inflammatory diseases where there is a strong biological rationale. The CoTikiS clinical results support progressing Luzvertikimab's development and brings us closer to our goal of delivering a long-acting therapy designed to treat the underlying disease pathophysiology.' OVERVIEW OF COTIKIS EXTENSION PERIOD (OLE) FINDINGS1 Lusvertikimab demonstrated a deepening of treatment response and durable response, with a high rate of symptomatic remission.1 89% of participants entered the OLE period and 87% of them completed the study. Rates of symptomatic remission6 improved for all dose groups in the OLE period, suggesting a deepening of efficacy. For participants who had received the 850 mg dose from the beginning of the study, rates plateaued already after Week 14; rates of symptomatic remission continued to improve through week 26 for the 450 mg induction group (10 weeks of 450 mg, 16 weeks of 850 mg dosing) and through week 34 for the group receiving placebo in the induction phase (10 weeks of placebo, 14 weeks of 850 mg Lusvertikimab). 92% of participants who had achieved symptomatic remission with either dose of Lusvertikimab in the induction period maintained it through the OLE period7 including 100% of those who achieved remission in the 850 mg dose group. 61% of participants who had not achieved symptomatic remission with either dose of Lusvertikimab in the induction period went on to achieve it during the OLE period. 85% of participants who had been in the placebo arm during the induction period went on to achieve symptomatic remission after receiving 850 mg in the OLE period. 82% of participants achieved remission of rectal bleeding by the end of the OLE. Lusvertikimab was well tolerated over a 34-week treatment period, with a good safety profile and without a higher rate or severity of infection. ABOUT THE COTIKIS STUDY1-3 CoTikiS, a randomized, double-blind, placebo-controlled 50-week clinical study,2 consisted of: A 10-week induction period evaluating two doses (450 mg or 850 mg) of Lusvertikimab versus placebo; A 24-week OLE period in which all participants received Lusvertikimab 850 mg infusions every four weeks; and A 16-week safety follow-up period without treatment. Findings from the induction phase of the CoTikiS study were presented in February at the 2025 ECCO congress. Both doses met the primary efficacy endpoint (improvement in Modified Mayo Score at Week 10) and demonstrated statistically significant and clinically meaningful results on secondary clinical, endoscopy and histology endpoints.3 REFERENCES / FOOTNOTES Bourreille A et al., Oral presentation #913, Digestive Disease Week, 5 May 2025, San Diego, USA. Bourreille A et al., J Crohn's & Colitis 2025; 19(1):i71–i72. doi: 10.1093/ecco-jcc/jjae190.0036. EU Clinical Trials Register: CoTikiS study record (2020-001398-59), available via [Accessed May 2025]. Yanofsky R & Rubin DT, J Can. Assoc. Gastroenterology 2025;8(S2):S6–S14, doi: 10.1093/jcag/gwae058. Le Berre C et al. Lancet 2023;402(10401):571–584, doi: 10.1016/S0140-6736(23)00966-2. Symptomatic remission on Mayo patient-reported outcomes 2, PRO2 (stool frequency subscore + rectal bleeding subscore) = 0 or 1 and rectal bleeding subscore = 0. Responders are defined as patients with endoscopic score of 0 or 1 at Week 10. ABOUT DIGESTIVE DISEASE WEEK (DDW)Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 3-6, 2025. The meeting showcases nearly 6,000 abstracts and over 1,000 invited talks on the latest advances in GI research, medicine and technology. More information can be found at 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: Follow us on LinkedIn. Contacts Fiona Dé French Media Contact FP2COMFlorence Portejoiefportejoie@ 6 07 768 283 U.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, 2025, including the annual financial report for the fiscal year 2024, 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. Attachment EN_250505_DDW Lusvertikimab_FINAL
Yahoo
09-04-2025
- Health
- Yahoo
OSE Immunotherapeutics to Present Groundbreaking Extension Period Data on Lusvertikimab at DDW 2025
OSE Immunotherapeutics to Present Groundbreaking Extension Period Data on Lusvertikimab at DDW 2025New Clinical Data from Phase 2 Extension Period in Ulcerative Colitis on Long-Term Benefits and Safety of Anti-IL-7R mAb Lusvertikimab NANTES, France – April 9, 2025, 7:30 a.m. CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a biotech company dedicated to developing first-in-class therapies in immuno-oncology and immuno-inflammation, today announced that the Company will present further efficacy and safety data1 from the 24-week Open Label Extension (OLE) period from CoTikiS Phase 2 clinical study of Lusvertikimab in ulcerative colitis at the Digestive Disease Week conference in San Diego (May 3 – 6, 2025). Following the excellent efficacy and safety profile from the trial's induction period presented as a highlight at the 2025 ECCO congress, this oral presentation will unveil new clinical data from the 24-week Open Label Extension (OLE) period (Week 10 to Week 34) of the randomized, double-blind, placebo-controlled Phase 2 study evaluating the anti-IL-7 receptor monoclonal antibody Lusvertikimab in moderate to severe ulcerative colitis. These new findings are expected to provide deeper insights into the long-term benefits and safety of Lusvertikimab, supporting further development in ulcerative colitis, as well as in other chronic autoimmune and inflammatory diseases. Presentation details: Title: 'LUSVERTIKIMAB, A FIRST IN CLASS IL7 RECEPTOR ANTAGONIST, IN MODERATE TO SEVERE ULCERATIVE COLITIS: RESULTS OF A MULTICCENTER RANDOMIZED PLACEBO-CONTROLLED PHASE II STUDY' Date and Time: Monday, May 05, 2025, from 4:45pm to 5:00pm Pacific TimeSession Presentation: Clinical Trials in IBD: Biologics and Emerging TherapiesSession Number: 0004 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 Japan2. Despite broad therapeutic options, remission rates are only 25-30%3 leaving most patients without satisfactory treatments. 15% of patients4 fail to respond to all therapies and undergo surgery as a last option. 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: Follow us on Fiona Dé French 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 The abstract was submitted before the completion of the 24-week Open Label Extension (OLE) period. The new data to be presented at DDW 2025 includes additional findings not available at the time of submission.2 Evaluate Pharma3 Drugs Context. 2019; 8: 212572 –doi: 10.7573/dic.2125724 Scientific Reports volume 10, Article number: 12546 (2020) Attachment EN_250409_DDW_Lusvertikimab_vfSign in to access your portfolio
Yahoo
09-04-2025
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OSE Immunotherapeutics to Present Groundbreaking Extension Period Data on Lusvertikimab at DDW 2025
OSE Immunotherapeutics to Present Groundbreaking Extension Period Data on Lusvertikimab at DDW 2025New Clinical Data from Phase 2 Extension Period in Ulcerative Colitis on Long-Term Benefits and Safety of Anti-IL-7R mAb Lusvertikimab NANTES, France – April 9, 2025, 7:30 a.m. CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a biotech company dedicated to developing first-in-class therapies in immuno-oncology and immuno-inflammation, today announced that the Company will present further efficacy and safety data1 from the 24-week Open Label Extension (OLE) period from CoTikiS Phase 2 clinical study of Lusvertikimab in ulcerative colitis at the Digestive Disease Week conference in San Diego (May 3 – 6, 2025). Following the excellent efficacy and safety profile from the trial's induction period presented as a highlight at the 2025 ECCO congress, this oral presentation will unveil new clinical data from the 24-week Open Label Extension (OLE) period (Week 10 to Week 34) of the randomized, double-blind, placebo-controlled Phase 2 study evaluating the anti-IL-7 receptor monoclonal antibody Lusvertikimab in moderate to severe ulcerative colitis. These new findings are expected to provide deeper insights into the long-term benefits and safety of Lusvertikimab, supporting further development in ulcerative colitis, as well as in other chronic autoimmune and inflammatory diseases. Presentation details: Title: 'LUSVERTIKIMAB, A FIRST IN CLASS IL7 RECEPTOR ANTAGONIST, IN MODERATE TO SEVERE ULCERATIVE COLITIS: RESULTS OF A MULTICCENTER RANDOMIZED PLACEBO-CONTROLLED PHASE II STUDY' Date and Time: Monday, May 05, 2025, from 4:45pm to 5:00pm Pacific TimeSession Presentation: Clinical Trials in IBD: Biologics and Emerging TherapiesSession Number: 0004 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 Japan2. Despite broad therapeutic options, remission rates are only 25-30%3 leaving most patients without satisfactory treatments. 15% of patients4 fail to respond to all therapies and undergo surgery as a last option. 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: Follow us on Fiona Dé French 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 The abstract was submitted before the completion of the 24-week Open Label Extension (OLE) period. The new data to be presented at DDW 2025 includes additional findings not available at the time of submission.2 Evaluate Pharma3 Drugs Context. 2019; 8: 212572 –doi: 10.7573/dic.2125724 Scientific Reports volume 10, Article number: 12546 (2020) Attachment EN_250409_DDW_Lusvertikimab_vf
Yahoo
06-03-2025
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OSE Immunotherapeutics Hosts KOL Webinar Post-ECCO on Lusvertikimab and the Future of IBD
OSE Immunotherapeutics Hosts KOL Webinar Post-ECCO on Lusvertikimab and the Future of IBD NANTES, France – March 6, 2025, 6:00pm CET - OSE Immunotherapeutics recently hosted a webinar featuring key opinion leaders (KOLs) to discuss the latest clinical trial results and scientific data on Lusvertikimab, particularly its positive outcomes in treating ulcerative colitis (UC). The webinar included insights from: Prof Laurent Peyrin-Biroulet, Professor of Gastroenterology, Nancy University Hospital, France, Prof Arnaud Bourreille, Associate Professor of Gastroenterology, Institut des Maladies de l'Appareil Digestif, Nantes University Hospital, Prof Vipul Jairath, Gastroenterologist and Professor of Medicine in the Schulich School of Medicine and Dentistry, Ontario, Canada, Nicolas Poirier, CEO of OSE Immunotherapeutics. These experts highlighted the significance of Lusvertikimab's clinical trial results within the current research and therapeutic landscape. They also discussed how these advancements address unmet patient needs and their potential impact on patient care. Additionally, the webinar provided an overview of the current therapeutic landscape in Inflammatory Bowel Diseases (IBD), with a focus on UC. FULL WEBINAR VIDEO: 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 information about OSE Immunotherapeutics assets is available on the Company's website: Follow us on X and LinkedInContacts Fiona Dé French 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. Attachment EN_250306_Post KOL webinarSign in to access your portfolio
