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

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 MaintenancePatients treated with a de-escalated dose of 25 mg of obefazimod once daily demonstrated maintenance of clinical remission at weeks 48 and 96Efficacy and safety demonstrated out to six years of treatmentThe treatment was well-tolerated, with a safety profile consistent with previous studies and no new safety signals detectedPARIS, France, October 3, 2024, 8:30 a.m. CEST – Abivax SA ((Euronext Paris &, NASDAQ:ABVX) ("Abivax" or the "Company"), a clinical-stage biotechnology company focused on developing therapeutics that harness the body's natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, announced the results of an interim efficacy and safety analysis of an open-label maintenance (OLM) study that enrolled patients with UC at the conclusion of the Phase 2a and Phase 2b OLM studies, where they had received obefazimod 50mg once daily. The data demonstrated maintenance of clinical remission and a safety profile consistent with prior studies of oral, once-daily obefazimod when administered at a reduced dose of 25mg for up to an additional two years."These important data further support the potential of obefazimod as a promising therapeutic option for patients with UC," said Marla Dubinsky, MD, Co-Director, Susan and Leonard Feinstein IBD Clinical Center at Icahn School of Medicine at Mount Sinai New York. "The results observed at a lower dose are particularly encouraging, as clinicians often like to have the option to de-escalate dosing once patients achieve remission".In this open-label maintenance study, patients who had completed the 4-year Phase 2a or 2-year Phase 2b OLM studies, where they had received 50 mg of once-daily obefazimod, were given the opportunity to continue receiving obefazimod at a reduced dose of 25mg daily for up to five additional years (provided they met the eligibility criteria of Mayo Endoscopic Subscore = 0 or 1). A total of 130 patients entered the study, as of Sep 11, 2024, the data cut-off date, 113 have been evaluated out to 48 weeks and 74 have undergone the full 96-week evaluation.At study baseline, 89% (116/130) of patients were in clinical remission. At weeks 48 and 96 of treatment, 84% (95/113) and 87% (64/74) of patients evaluated were in clinical remission, respectively. Similarly, 92% (119/130) of ...Full story available on Benzinga.com