Abivax's ABTECT Phase 3 Trial Hits Key Enrollment Milestone

Abivax, a clinical-stage biotechnology firm, has accomplished a significant milestone in its Phase 3 ABTECT Trial. The trial, which is evaluating obefazimod in patients with moderately to severely active ulcerative colitis (UC), has now surpassed the 600-patient enrollment mark as of July 2024. This progress suggests that the trial is on track to complete full enrollment by early Q1 2025.

Obefazimod is Abivax's lead investigational drug candidate. It is an orally administered small molecule that has shown potential in enhancing the expression of miR-124, a specific microRNA. Positive data from Phase 2 clinical trials in UC patients led to the initiation of the pivotal global Phase 3 ABTECT program. The first patients for this trial were enrolled in the United States in October 2022. Furthermore, the company plans to commence a Phase 2b clinical trial for Crohn’s disease in Q3 2024 and is also investigating potential combination therapy opportunities in UC.

Abivax is based in France and the United States and is dedicated to developing treatments that leverage the body’s natural regulatory mechanisms to stabilize immune responses in chronic inflammatory diseases. The company’s focus on harnessing the body's own regulatory processes aims to provide more effective and lasting treatments for conditions like ulcerative colitis.

The successful enrollment of over 600 patients in the Phase 3 ABTECT trial is a crucial step toward achieving full enrollment and eventually, potential regulatory approval. Abivax’s corporate presentation, updated with these new milestones, is available on their website.

The company's lead candidate, obefazimod, has shown promise in earlier clinical phases, which has fueled optimism for its continued development. The ongoing Phase 3 trial is essential for validating the efficacy and safety of obefazimod in a larger patient population, which is a critical step before seeking regulatory approvals and eventually bringing the drug to market.

In summary, Abivax's achievement in enrolling over 600 participants in its Phase 3 ABTECT trial marks a key milestone in the ongoing development of obefazimod for the treatment of moderately to severely active ulcerative colitis. The company remains on track to complete full enrollment by early Q1 2025, with additional plans to explore its potential in treating Crohn’s disease and other combination therapies.