Abivax reported positive Phase 3 results for obefazimod, a first-in-class oral miR-124 enhancer, in two induction trials for moderate to severe ulcerative colitis (UC). The 50mg once-daily dose achieved a statistically significant 16.4% placebo-adjusted clinical remission rate at week 8. This positive data comes from the ABTECT-1 and ABTECT-2 trials, which together constitute one of the most significant Phase 3 UC studies ever conducted, notably including a substantial cohort of patients with inadequate responses to JAK inhibitor therapy.
These findings have the potential to be transformative for the treatment landscape of UC. Obefazimod offers a novel mechanism of action through miR-124 enhancement, distinct from existing therapies. The significant clinical remission rate observed, particularly in a population with prior treatment failures including JAK inhibitors, suggests obefazimod could address an unmet need for patients who don’t respond to current standards of care. The large trial size and global scope strengthen the robustness of these results and potentially position obefazimod for broad market access.
Both trials met the FDA primary endpoint of clinical remission at week 8 with the 50mg dose. Secondary endpoints, including endoscopic improvement and clinical response, were also met. The 25mg dose demonstrated a strong signal for clinical response, suggesting potential benefit with longer-term treatment. Importantly, obefazimod maintained a favorable safety profile with no new safety signals detected. 678 of the 1,275 participants from the induction trials have transitioned to the ongoing maintenance trial, with results expected in Q2 2026. Preliminary cash and cash equivalents for Abivax stood at approximately $71.4 million as of June 30, 2025.
Positive results from the ongoing maintenance trial could pave the way for Abivax to submit a New Drug Application to the FDA and a Marketing Authorization Application to the European Medicines Agency in the latter half of 2026. This could mark a significant advancement in UC treatment, offering a new option for patients who have exhausted existing therapeutic avenues. The novel mechanism of action may also spur further research into miR-124 modulation for other inflammatory conditions.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
