Latest news with #CoTikiS
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_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
- 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_vf
Yahoo
24-02-2025
- Health
- Yahoo
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
