Abivax Enrolls First Patient in Phase 2b Crohn’s Disease Trial of Obefazimod

Abivax Commences Enrollment in ENHANCE-CD Phase 2b Trial for Crohn’s Disease

PARIS, France, October 3, 2024 – Abivax SA, a clinical-stage biotechnology company, has announced the enrollment of the first patient in its Phase 2b ENHANCE-CD trial. This trial is designed to evaluate the efficacy and safety of obefazimod in patients suffering from Crohn’s disease (CD).

The ENHANCE-CD trial, registered under NCT06456593, is a multicenter, double-blind, randomized, placebo-controlled study. It aims to assess the therapeutic potential of obefazimod, administered once daily, in adults with moderate to severe Crohn’s disease.

According to Dr. Fabio Cataldi, Abivax’s Chief Medical Officer, the enrollment of the first patient marks a critical step towards providing a convenient, oral, once-daily treatment option for those afflicted by moderate to severe Crohn’s disease. This milestone moves Abivax closer to addressing the unmet needs of patients seeking effective, less burdensome therapies.

The trial comprises three phases: a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase. The primary goal of the Induction and Maintenance Phases is to evaluate the efficacy and safety of obefazimod compared to a placebo in patients with moderate to severe CD who have shown inadequate response to existing conventional or advanced therapies. The 48-Week Extension Phase specifically aims to further assess the safety and tolerability of obefazimod.

Obefazimod, also known as ABX464, is Abivax’s leading investigational drug candidate. It is an orally administered small molecule with the potential to enhance the expression of a single microRNA, miR-124. Previous Phase 2 clinical trials in patients with ulcerative colitis (UC) have yielded positive results, prompting the initiation of a pivotal global Phase 3 clinical trial program known as the ABTECT Program. The first patients for this program were enrolled in the United States in October 2022. The ongoing Phase 2b trial for Crohn’s disease, which began enrolling patients in October 2024, aims to explore the drug’s potential in a new patient population. Additionally, Abivax is investigating the possibilities for combination therapy in UC.

Abivax is a biotechnology company committed to developing treatments that leverage the body's natural regulatory mechanisms to stabilize the immune response in chronic inflammatory diseases. With operations in both France and the United States, Abivax’s innovative approach focuses on creating therapies that can significantly improve the lives of patients.

The initiation of the ENHANCE-CD trial showcases Abivax's dedication to advancing therapeutic options for chronic inflammatory conditions. Obefazimod represents a promising solution for managing Crohn’s disease, aiming to fill the gaps left by current treatment options that may not provide sufficient relief or may come with significant side effects.

This pivotal trial will provide valuable insights into the potential of obefazimod to become a new, effective treatment for Crohn’s disease, presenting a hopeful prospect for patients who have struggled with finding adequate therapies.

In summary, Abivax’s commencement of the ENHANCE-CD Phase 2b trial signifies a noteworthy advancement in the quest to develop effective treatments for Crohn’s disease. By focusing on the unmet needs of patients, Abivax aims to deliver innovative solutions that could transform the management of chronic inflammatory diseases.