Abivax Receives French Regulatory Authority (ANSM) Approval to Include French Study Sites in its Phase 2b Ulcerative Colitis Clinical Trial and Provides a Progress Update of the ABX464 Clinical Development Plan in other Inflammatory Diseases
ABIVAX SA (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, announced that the French National Regulatory Authority (ANSM) has approved the ABX464-103 Phase 2b study of its lead product candidate ABX464 with once a day convenient oral dosing for treatment of patients with moderate to severe active ulcerative colitis (UC).
Prof. Dr. Hartmut J. Ehrlich M.D., Chief Executive Officer of Abivax said: “We are very pleased with ANSM giving us the green light for the continued clinical development of this promising compound in France. As presented during UEG week in Barcelona (October 19-23, 2019), our proof of concept phase 2a studies with ABX464 in patients with moderate to severe UC showed that 75% of all evaluable patients were in clinical remission and therefore essentially free of symptoms after 2 months induction and 12 months maintenance. This remarkable percentage of clinical remissions is further strengthened by a 78% reduction of the total mayo score, a 89% reduction of the endoscopic subscore and a 97% reduction of biomarker fecal calprotectin (normalized). With the ABX464-103 study (Phase 2b), we are planning to confirm these excellent outcomes in a statistically relevant number of patients and, at the same time, evaluate different doses of ABX464 to define the optimal dose for subsequent Phase 3 testing. We are looking forward to advancing this exciting program with ABX464, a novel, first-in-class molecule with an innovative mode of action that could make a difference in treating patients suffering from this emaciating inflammatory disease.”
Dr. Jean-Marc Steens, Chief Medical Officer of Abivax, added: “So far, our study results with ABX464 are truly remarkable. With currently available treatments, including biologics, typically only 10-25% of the patients achieve clinical remission after 2 months of induction, and half of the responders stop responding after six to twelve months, so there is a large unmet need for effective ulcerative colitis therapies. This is a debilitating disease that greatly affects patients’ quality of life and requires expensive and cumbersome therapies. The innovative mechanism of action of ABX464 and data from this trial represent a promising new potential approach to the treatment of ulcerative colitis that could provide these patients with an easily administered, once-daily oral, long-term therapeutic management option.”