Abivax's Phase 2b Trial of Obefazimod for Crohn's Disease Enrolls First Patient
核心洞察
Abivax has initiated its Phase 2b ENHANCE-CD trial, with the first patient enrolled to evaluate obefazimod in Crohn's disease (搜索).
The trial is a multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of once-daily obefazimod in adults.
The study includes a 12-week induction phase, a 40-week maintenance phase, and a 48-week extension phase to assess long-term safety.
Abivax SA has announced the enrollment of the first patient in its Phase 2b ENHANCE-CD clinical trial (NCT06456593) evaluating obefazimod for the treatment of Crohn's disease (搜索). This milestone marks a significant step forward in addressing the unmet needs of patients with moderately to severely active Crohn's disease who require effective and convenient treatment options. The trial aims to assess the efficacy and safety of obefazimod as both an induction and maintenance therapy.
The ENHANCE-CD trial is a multicenter, double-blind, randomized, placebo-controlled study. It will evaluate the efficacy and safety of obefazimod, administered once daily, in adult patients with moderately to severely active Crohn's disease (搜索). These patients have shown an inadequate response, loss of response, or intolerance to conventional and/or advanced therapies.
Trial Design and Objectives
The trial is structured into three phases: a 12-week induction phase, a 40-week maintenance phase, and a 48-week extension phase. The primary objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy. The 48-week extension phase will focus on assessing the long-term safety and tolerability of obefazimod.
Fabio Cataldi, MD, Abivax Chief Medical Officer, stated, "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."
About Obefazimod
Obefazimod is an orally administered small molecule and Abivax’s lead investigational drug candidate. It has demonstrated the potential to enhance the expression of microRNA miR-124 (搜索), which plays a role in stabilizing the immune response. Prior Phase 2 clinical trials in ulcerative colitis (搜索) patients have yielded positive data, leading to the initiation of a pivotal global Phase 3 clinical trial program (ABTECT Program).