Abivax Announces Late-Breaking Presentation of 8-Week ABTECT Trial Results with Updated Safety Data

Abivax Announces Late-Breaking Presentation of 8-Week ABTECT Trial Results with Updated Safety Data

• 50 mg once-daily dose of obefazimod led to a pooled 16.4% (p<0.0001) placebo-adjusted clinical remission rate at Week 8; met primary and all key secondary endpoints in both ABTECT 1 and ABTECT 2
  
  
• ABTECT trials enrolled refractory patient population with 47% of participants having prior inadequate response to advanced therapy, among whom 21% had prior inadequate response to JAK inhibitor therapy
  
  
• Obefazimod treatment was well tolerated with no new safety signals identified for both the 25mg and 50mg doses
  
  
• Abivax to present a second late-breaking abstract on October 6. Management to host a conference call to discuss results of both late-breaking abstracts at 9am ET / 3pm CET on October 6.
  
  

PARIS, France – October 05, 2025 – 5:00 PM CET – Abivax SA (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 results from the first of two late-breaking presentations at the United European Gastroenterology (UEG) Meeting in Berlin, Germany. The presentation includes results from Abivax’s Phase 3 ABTECT 8-Week Induction Trials investigating obefazimod for the treatment of moderate-to-severely active ulcerative colitis, including previously reported findings and additional safety data at week 8.

“There is an urgent need for new therapies to treat ulcerative colitis that deliver durable efficacy, safety, and the simplicity of oral, once-daily dosing,” said Bruce Sands, MD*, Professor of Medicine, Icahn School of Medicine at Mount Sinai. "The ABTECT Trials enrolled individuals with advanced disease, including many who had failed multiple lines of advanced therapy and a significant percentage of patients with prior JAK inhibitor failure. The refractory nature of this population underscores the significance of the results presented today.”

A total of 1272 patients were enrolled across the ABTECT 1 & 2 trials. In the pooled full data set across ABTECT 1 & 2, no signal for serious, severe, or opportunistic infections or malignancies was observed. The most commonly reported TEAEs were headache (6%-placebo, 16%-25mg, 24.1%-50mg) with <1% of headaches leading to study discontinuation (0.3% at 25mg; 1.1% at 50mg), and nausea (1.3% in placebo, 5.0% at 25mg, 7.2% at 50mg).