Abivax has shared positive top-line results from two late-stage studies of its investigational oral miR-124 enhancer in adults with moderately to severely active ulcerative colitis (UC).
The phase 3 ABTECT-1 and ABTECT-2 induction trials have been evaluating once-daily 25mg and 50mg doses of the candidate, obefazimod (ABX464), in UC patients who have had an inadequate response, loss of response, or intolerance to conventional and/or advanced therapies.
Both trials met the US Food and Drug Administration (FDA) primary endpoint of clinical remission at week eight among the 50mg dosing groups, with placebo-adjusted clinical remission rates of 19.3% and 13.4% in ABTECT-1 and ABTECT-2, respectively.
The 25mg group also achieved the clinical remission primary endpoint at week eight in ABTECT-1, demonstrating a placebo-adjusted remission rate of 21.4%, and while the 25mg cohort did not achieve statistical significance for this endpoint in ABTECT-2, it achieved a pooled placebo-adjusted clinical response rate of 28.6%.
All key secondary efficacy endpoints were met in both trials, and the safety profile of obefazimod remained consistent with prior clinical experience.
The phase 3 ABTECT maintenance trial of the drug is ongoing, with top-line results expected next year.
Abivax’s chief executive officer, Marc de Garidel, said: “The strength of these results reinforces our belief in obefazimod, our first-in-class miR-124 enhancer, and its potential to become a transformative new treatment modality for patients with UC.
“Pending successful results from the 44-week maintenance trial, we are preparing to submit a New Drug Application to the FDA in the second half of 2026.”
UC is a chronic, immune-mediated condition where the colon and rectum become inflamed, causing symptoms such as persistent diarrhoea and abdominal pain. The condition is one of the two main types of inflammatory bowel disease, which affects nearly one in every 100 people in the US.
Obefazimod is designed to enhance the expression of microRNA-124, a natural regulator of the inflammatory response.
The company’s chief medical officer, Fabio Cataldi, said: “We are thrilled to report outcomes that not only met but exceeded the bar set by our phase 2b trial, a remarkable achievement that speaks volumes about the quality of our development programme.
“We look forward to presenting more detailed analysis, including patients with inadequate response to prior JAK therapy at an upcoming medical conference.”