Abivax Announces First Patient Enrolled in Phase 2b Trial of Obefazimod in Crohn’s Disease
Abivax SA recently announced the first patient was enrolled in its Phase 2b ENHANCE-CD (NCT06456593) trial evaluating obefazimod in patients with Crohn’s disease (CD). The multicenter, double-blind, randomized, placebo-controlled trial will evaluate the efficacy and safety of obefazimod, administered once daily, in adults with moderately to severely active Crohn’s disease.
Fabio Cataldi, MD, Abivax Chief Medical Officer, said “The enrollment of the first patient in our Phase 2b trial marks a significant step forward in meeting the need for a convenient, oral, once-daily treatment option for people with moderately to severely active Crohn’s disease. This milestone brings us closer to addressing the unmet needs of patients seeking effective therapies with fewer burdens on their daily lives.”
This trial has 3 treatment phases: a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase. The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response (no response, loss of response, or intolerance) to conventional therapies and/or advanced therapies. The primary objective for the 48-Week Extension Phase is to evaluate the safety and tolerability of obefazimod compared to placebo in subjects who are enrolled in the Extension Phase.
Obefazimod, Abivax’s lead investigational drug candidate, is an orally administered small molecule that was demonstrated to potentially enhance the expression of a single microRNA, miR-124. Phase 2 clinical trials in patients with UC have generated positive data, resulting in the initiation of a pivotal global phase 3 clinical trial program (ABTECT Program), with first patients enrolled in the United States in October 2022. A Phase 2b clinical trial in Crohn’s disease is ongoing, with the first patient enrolled in October 2024, and exploration of potential combination therapy opportunities in UC is ongoing.
Abivax is 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. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. For more information, visit www.abivax.com.
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