Core Insights - Abivax reported positive interim efficacy and safety results for obefazimod in patients with moderate to severe ulcerative colitis after two years of open-label maintenance treatment [1][2][3] - The treatment demonstrated maintenance of clinical remission and a favorable safety profile, with no new safety signals detected [1][3][4] Efficacy Results - At study baseline, 89% of patients were in clinical remission, with 84% and 87% maintaining remission at weeks 48 and 96, respectively [3] - Symptomatic remission was observed in 92% of patients at baseline, with 91% and 92% at weeks 48 and 96, respectively [3] - The study included 130 patients, with 113 evaluated at 48 weeks and 74 at 96 weeks [2][3] Safety Profile - The treatment was well-tolerated, with a patient retention rate of 88% in the first year and 95% in the second year [3] - Only 12% of patients discontinued in the first year and 5% in the second year, indicating strong adherence to the treatment [3] Future Developments - Abivax is advancing obefazimod into a pivotal global Phase 3 clinical trial program, with the first patients enrolled in the U.S. in October 2022 [5] - A Phase 2b clinical trial in Crohn's disease is expected to begin in Q4 2024, along with ongoing exploration of combination therapy opportunities in ulcerative colitis [5] Company Overview - Abivax is a clinical-stage biotechnology company focused on developing therapeutics that stabilize the immune response in chronic inflammatory diseases [6] - The company is based in France and the United States, with obefazimod as its lead investigational drug candidate [6]
Abivax Reports Positive Interim Efficacy and Safety Analysis of Once-Daily 25mg Obefazimod in Moderate to Severe Ulcerative Colitis Patients After 2-Years of Open-Label Maintenance