Abivax Announces Landmark Phase 3 ABTECT Maintenance Trial Results Evaluating Obefazimod in Moderately to Severely Active Ulcerative Colitis

Abivax Announces Landmark Phase 3 ABTECT Maintenance Trial Results Evaluating Obefazimod in Moderately to Severely Active Ulcerative Colitis

• At Week 44, both the 25 mg and 50 mg once-daily obefazimod doses met the primary endpoint, demonstrating placebo-adjusted clinical remission rates of ∆39.3% and ∆40.3%, respectively (25 mg: 50.8%, 50 mg: 51.3% vs placebo 10.4%; p<0.0001)
  
  
• Both 25 mg and 50 mg obefazimod met all key secondary endpoints, demonstrating robust and clinically meaningful efficacy results across multiple measures of disease control
  
  
• Obefazimod demonstrated a favorable safety profile over the 44-week maintenance trial (N=580), with no new safety signals
  
  
• Recently reported Phase 2a/2b open-label extension data (Study 108) demonstrated durable clinical remission and a favorable safety profile with up to seven years of exposure
  
  
• The Company plans to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for obefazimod in ulcerative colitis in late Q4 2026
  
  
• Topline results of Phase 2b induction trial for Crohn’s disease expected mid-year 2027
  
  
• Abivax to host a conference call and webcast today at 4:30 p.m. EDT (10:30 p.m. CEST) to discuss the results
  
  

PARIS, France – June 1, 2026 – 10:05 pm CEST – Abivax SA (https://www.globenewswire.com/Tracker?data=2QKhT35dNpfISAvNY09ep4GCCY27xxhk3QRzNbuUQ6iB2ZL8exXCuohRkQ6rcJMhSfa_T3Zdc1TqhU-mOACdqQ==) (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), 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, today announced positive topline results from the Phase 3 ABTECT maintenance trial evaluating obefazimod, its investigational oral, first-in-class miR-124 enhancer, in adults with moderately to severely active ulcerative colitis (“UC”). The results demonstrate that both the 25 mg and 50 mg doses of obefazimod met the primary endpoint of clinical remission and all key secondary endpoints at Week 44.

Marc de Garidel, MBA, Chief Executive Officer of Abivax, said: “Today’s landmark Phase 3 results highlight the exceptional potential of obefazimod to redefine the treatment landscape for ulcerative colitis. With its compelling durable efficacy and favorable safety profile, combined with the convenience of a once-daily oral treatment, obefazimod has the potential to transform UC patient care.”

David T. Rubin, M.D., Chief, Section of Gastroenterology, Hepatology and Nutrition, and Director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine, commented: “The 44-week maintenance data demonstrate obefazimod’s potential to deliver meaningful efficacy and durable disease control in ulcerative colitis. The novel mechanism, sustained clinical remission, and favorable long-term safety profile highlight its potential to address a significant unmet need in UC.”

Topline Results

The Phase 3 ABTECT maintenance trial is a global 44-week multicenter, randomized, double-blind, placebo-controlled trial that evaluated the long-term efficacy and safety of obefazimod at 25 mg and 50 mg administered orally once-daily in adults with moderately to severely active UC. Participants who were clinical responders after the 8-week ABTECT-1 and ABTECT-2 induction trials (N=580) were re-randomized to receive 25 mg obefazimod, 50 mg obefazimod, or placebo.

Results from the trial demonstrated that obefazimod met the FDA primary endpoint of placebo-adjusted clinical remission at Week 44 in the 25 mg (∆39.3%, p<0.0001) and 50 mg (∆40.3%, p<0.0001) once-daily dose regimens in the Phase 3 maintenance trial. The trial also recorded a 10.4% placebo clinical remission rate, the lowest reported to date in a Phase 3 UC maintenance responder re-randomization trial.

Both doses of obefazimod met all key secondary endpoints (endoscopic improvement, endoscopic remission, HEMI1, corticosteroid free clinical remission, and sustained clinical remission), demonstrating robust and clinically meaningful efficacy results across multiple measures of disease control.

Obefazimod demonstrated an overall favorable safety profile in the Phase 3 ABTECT maintenance trial with no new safety signals observed, and the treatment was generally well tolerated.

Abivax intends to submit an NDA to the FDA in late fourth quarter 2026.

Learn more in the Abivax press release.