Abivax’s Obefazimod Achieves Primary Endpoint in Two Global Phase 3 Trials for Ulcerative Colitis

Abivax’s Obefazimod Achieves Primary Endpoint in Two Global Phase 3 Trials for Ulcerative Colitis

By, Admin 25 July 2025

French biotech firm Abivax SA has reported positive topline results from its pivotal Phase 3 induction trials, ABTECT-1 and ABTECT-2, evaluating its first-in-class oral miR-124 enhancer, obefazimod (ABX464), in adult patients with moderately to severely active ulcerative colitis (UC).

The trials met FDA-defined primary endpoints for clinical remission at Week 8, particularly at the 50 mg dose, and demonstrated strong signals of efficacy across key secondary endpoints.

Phase 3 Induction Trials: A Global Effort

ABTECT-1 (Study 105) and ABTECT-2 (Study 106) are part of one of the largest ulcerative colitis programs ever conducted. Both were:

  • Randomised, double-blind, placebo-controlled
  • Included 1,275 adult patients across 600+ sites in 36 countries
  • Focused on patients with inadequate response, loss of response, or intolerance to conventional or advanced therapies, including JAK inhibitors
  • Evaluated once-daily oral dosing at 25 mg and 50 mg

Trial Results at a Glance

Obefazimod 50 mg, once-daily:

  • ABTECT-1: Placebo-adjusted clinical remission rate of 19.3% (p<0.0001)
  • ABTECT-2: Placebo-adjusted clinical remission rate of 13.4% (p=0.0001)
  • Met all key secondary efficacy endpoints in both trials

Obefazimod 25 mg, once-daily:

  • ABTECT-1: Achieved statistical significance with 21.4% placebo-adjusted remission
  • ABTECT-2: Did not reach significance for remission but showed a 28.6% placebo-adjusted clinical response rate, suggesting potential with longer treatment

Safety Profile:

  • No new safety signals observed
  • Consistent with earlier studies
  • Well tolerated across both dose groups

A First-in-Class Approach: What Makes Obefazimod Unique?

Obefazimod (ABX464) is a novel miR-124 enhancer, targeting inflammation through immune modulation. It’s the first therapeutic candidate in its class to reach Phase 3 status for UC.

  • Oral delivery offers ease of use over injectable biologics
  • Potential for early-line treatment and use after biologic or JAK inhibitor failure
  • Targets chronic inflammation via upregulation of microRNA-124, a key regulator of immune homeostasis

Expert Reactions: Hope for a New Era in UC Treatment

Dr. Marc de Garidel, CEO of Abivax, called the results a "significant milestone":

“The strength of these results reinforces our belief in obefazimod... Pending success in the 44-week maintenance trial, we’re preparing for an FDA submission in H2 2026.”

Dr. David Rubin, Director of the IBD Center at University of Chicago Medicine, added:

“Obefazimod may become a welcome new option for UC patients — both as an early intervention and for those who’ve failed prior advanced therapies.”

What’s Next: Maintenance Trial and Regulatory Filing

  • ABTECT Maintenance Trial is ongoing with 678 responders from the induction trials have enrolled. Topline results expected in Q2 2026
  • Regulatory roadmap: NDA submission to FDA and MAA submission to EMA planned for H2 2026, pending maintenance results

Development Program Scale and Market Impact

  • Global ulcerative colitis program includes three pivotal trials
  • Evaluates over 1,200 patients with moderate-to-severe UC
  • Includes the largest cohort of patients unresponsive to JAK inhibitors

This expansive approach is designed to satisfy regulatory requirements globally, positioning obefazimod as a front-runner in next-generation inflammatory bowel disease (IBD) therapies.

Financial Note

Abivax has postponed its H1 2025 financial results from August 11 to September 8. Preliminary unaudited cash and cash equivalents as of June 30, 2025, stood at approximately $71.4 million (EUR 61.0 million).

Company Outlook

Dr. Fabio Cataldi, Chief Medical Officer at Abivax, summed up the company’s optimism:

“We exceeded the bar set by our Phase 2b study. The data shows both rigor and reproducibility, and we’re excited to present deeper analyses, especially among JAK inhibitor non-responders, at upcoming scientific conferences.”

If confirmed by the long-term maintenance results, obefazimod could emerge as a disruptive oral option in a market dominated by injectables and biologics, addressing both efficacy and convenience for UC patients worldwide.

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