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Study 108 interim data show 68% of UC patients remained in clinical remission at week 144 after de-escalating from 50 mg to 25 mg obefazimod daily.
Abivax has reported 3-year interim data from Study 108, a phase 2a/2b open-label extension trial of obefazimod (ABX464) in patients with moderately to severely active ulcerative colitis (UC).
Drug class: First-in-class oral miR-124 enhancer
Developer: Abivax
Indication in development: Moderately to severely active ulcerative colitis
Dosing: Once-daily oral tablet (25 mg or 50 mg)
Stage: Phase 3; NDA submission planned Q4 2026
As described in a May 22, 2026, company announcement, the intent-to-treat (ITT) analysis showed sustained clinical remission following dose de-escalation from 50 mg to 25 mg once daily, with no new safety signals identified in patients treated for up to 7 years.
Study 108 provides the longest-running efficacy and safety dataset available for obefazimod, a first-in-class oral miR-124 enhancer. The agent previously demonstrated statistically significant clinical remission in a pair of global phase 3 induction trials, ABTECT-1 and ABTECT-2, in July 2025, generating growing interest in its potential as an oral alternative for patients with inadequate response to conventional or advanced therapies, including JAK inhibitors.²
Study 108 enrolled patients who had completed either the 4-year phase 2a or 2-year phase 2b open-label maintenance trials, during which they received 50 mg once-daily obefazimod. To be eligible for dose de-escalation, participants were required to have a Mayo Endoscopic Subscore of 0 or 1.
A total of 130 patients de-escalated to 25 mg once daily for up to 5 additional years. As of the January 5, 2026, data cutoff, 80% (104/130) of patients had completed the full 144-week evaluation.¹
At study baseline, 89% (116/130) of patients were in clinical remission. At weeks 48, 96, and 144 of treatment on the reduced 25 mg dose, clinical remission rates were 73% (95/130), 69% (90/130), and 68% (88/130), respectively, per ITT analysis with non-responder imputation. The remission definition incorporated endoscopic subscore. According to Abivax, similar trends were observed across other efficacy analyses.¹
The safety profile of obefazimod remained consistent with prior clinical experience across up to 7 years of cumulative exposure in Study 108 patients, according to Abivax.¹ No new safety signals were identified. The tolerability data extend the long-term safety characterization of the agent beyond what was available from the induction trials and earlier maintenance studies.
In a statement, Abivax's Chief Medical Officer Fabio Cataldi, MD, said the data "supports the potential of obefazimod as a durable treatment option for people living with ulcerative colitis," citing both the durability of remission and the favorable tolerability profile over the observation period.¹
The ABTECT phase 3 maintenance trial (ABX464-107) remains ongoing. Among the 1275 patients randomized across the ABTECT-1 and ABTECT-2 induction trials, 678 who achieved clinical response enrolled in Part 1 of the maintenance trial, which evaluates 44-week outcomes. Abivax has updated the expected topline readout to late Q2 2026, with a planned New Drug Application submission to the FDA in Q4 2026 contingent on positive maintenance data.¹ The company also intends to submit a Marketing Authorization Application to the European Medicines Agency in the same timeframe.
The ENHANCE-CD trial evaluating obefazimod in Crohn's disease is also underway, with a 12-week induction data readout anticipated in Q4 2026.¹
