Abivax’s Phase 2b Trial Testing ABX464 for Ulcerative Colitis Cleared to Add French Sites

Abivax’s Phase 2b Trial Testing ABX464 for Ulcerative Colitis Cleared to Add French Sites
France's National Agency for the Safety of Medicine and Health Products (ANSM) has cleared the inclusion of French study sites for Abivax's new Phase 2b clinical trial, intended to evaluate several oral doses of its lead investigational therapy ABX464 for moderate-to-severe ulcerative colitis (UC). With the decision by the ANSM, the clinical trial (NCT03760003) for ABX464 is now fully approved in 15 countries and will run in nearly 150 study sites. Patient recruiting is ongoing. More information about trial contacts is available here. Top-line data from the study, which aims to enroll 232 patients with moderate-to-severe UC, is expected at the end of 2020. “We are very pleased with ANSM giving us the green light for the continued clinical development of this promising compound in France," Hartmut J. Ehrlich, MD, CEO of Abivax, said in a press release. The company recently presented promising results from the open-label extension study of ABX464 (NCT03368118). After one year of maintenance therapy with daily 50 mg capsules of ABX464, 75% of the evaluated patients — 12 out of 19 — were in clinical remission, meaning they are free of any symptoms of the disease. These patients had moderate-to-severe, active UC, and had previously failed other treatments, including immunomodulators, anti-TNF biologics, Entyvio, or corticosteroids. “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," said Jean-Marc Steens, MD, Abivax's chief medical officer. Th
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