PARIS, France, May 22, 2026
Abivax announced new three-year interim data from Study 108 showing that obefazimod maintained durable long-term clinical remission in patients with moderately to severely active ulcerative colitis (UC) following dose de-escalation from 50 mg to 25 mg daily. The updated Phase 2a/2b open-label extension analysis demonstrated that 68% of patients remained in clinical remission at Week 144, supporting the therapy’s potential as a long-term maintenance treatment for chronic inflammatory bowel disease. The company also reported that patients have now received obefazimod treatment for up to seven years with no new safety signals observed, further strengthening confidence ahead of upcoming Phase 3 readouts.
Durable Long-Term Remission Sustained After Dose Reduction
Study 108 enrolled patients who previously completed either the four-year Phase 2a or two-year Phase 2b maintenance studies involving 50 mg once-daily obefazimod therapy. Eligible participants with favorable endoscopic outcomes were transitioned to a reduced 25 mg dose for continued long-term treatment. A total of 130 patients entered the maintenance extension trial, and by the January 2026 data cutoff, 80% of participants remained enrolled and completed the full 144-week evaluation period.
According to the interim intent-to-treat analysis, 89% of patients were already in clinical remission at baseline before dose reduction. Clinical remission rates remained consistently strong over time, with 73% at Week 48, 69% at Week 96, and 68% at Week 144 despite lowering the treatment dose. Abivax stated that remission assessments included endoscopic outcomes using non-responder imputation analysis, reinforcing the robustness of the findings. The company believes the data indicate that obefazimod may provide sustained immune regulation and durable disease control even with reduced long-term dosing.
Safety Profile Supports Long-Term UC Maintenance Strategy
Advertisement
Abivax emphasized that no new safety signals were identified during prolonged exposure to obefazimod, including patients treated continuously for up to seven years across the broader clinical development program. The company noted that the therapy maintained a favorable tolerability profile throughout the extension period, an important consideration for chronic diseases such as ulcerative colitis that often require lifelong treatment.
Chief Medical Officer Dr. Fabio Cataldi stated that the durability of remission combined with long-term tolerability supports obefazimod’s potential as a meaningful maintenance therapy for UC patients who frequently experience relapse after existing treatments. Abivax also highlighted earlier data presented at ECCO 2026 showing preliminary anti-fibrotic activity alongside efficacy and safety signals in inflammatory bowel disease, suggesting broader therapeutic potential beyond symptom management alone.
Phase 3 UC Results Expected in Q2 2026
The company confirmed that topline results from the ABTECT Phase 3 maintenance trial are expected in late Q2 2026, representing a major catalyst for the program. Positive results could support a planned New Drug Application (NDA) submission in ulcerative colitis during Q4 2026. In parallel, Abivax is also advancing a Phase 2b Crohn’s disease program evaluating obefazimod in additional inflammatory bowel disease indications.
Financially, Abivax reported €491.6 million in cash, cash equivalents, and short-term investments as of March 31, 2026, which the company stated provides operational runway into Q4 2027. Research and development expenses increased year-over-year primarily due to expanded clinical development activities, manufacturing scale-up, and preparation for potential commercialization. The company continues to prioritize investment in late-stage inflammatory disease programs while preparing for potential regulatory filings and future market expansion.
Source: Abivax press release
