Abivax reports positive Phase 3 results from ABTECT Maintenance Part 2, showing obefazimod delivers clinical benefit in refractory ulcerative colitis and expands long‑term safety data ahead of planned FDA filing in late 2026.
Written By: Shaik Yasmeen, PharmD
Reviewed By: Pharmacally Editorial Team
Abivax has reported positive topline results from ABTECT Maintenance Part 2 (NCT05535946), the supplemental portion of its Phase 3 ulcerative colitis (UC) program evaluating investigational obefazimod, an oral miR-124 enhancer, in adults with moderately to severely active disease. The study showed meaningful clinical benefit in patients who did not respond to induction therapy or relapsed during maintenance, while substantially expanding the long-term safety database supporting the company’s planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration in the fourth quarter of 2026.
Scientific and Clinical Context
Ulcerative colitis is a chronic inflammatory bowel disease characterized by persistent inflammation of the colon, leading to symptoms such as bloody diarrhea, abdominal pain, and urgency. Many patients fail to respond adequately to currently available biologics and small-molecule therapies or lose response over time, highlighting the need for durable treatment options.
Obefazimod is an investigational oral small molecule that selectively enhances expression of microRNA-124 (miR-124), a natural regulator of inflammatory pathways. By restoring immune balance rather than directly suppressing a single inflammatory target, the therapy offers a novel mechanism for controlling chronic intestinal inflammation.
Clinical Benefit in Refractory UC
Maintenance Part 2 enrolled patients who either failed to achieve clinical response after eight weeks of induction therapy or experienced disease relapse during Maintenance Part 1, representing a highly treatment-refractory population.
Among induction non-responders who continued 50 mg obefazimod, 37.2% achieved clinical remission and 61.5% achieved clinical response by Week 44. The treatment also produced 48.0% endoscopic improvement, 44.6% histologic-endoscopic mucosal improvement (HEMI), and 34.5% endoscopic remission, indicating that prolonged treatment may benefit patients who initially show limited response.
Dose Escalation Restores Disease Control
The study also evaluated patients who relapsed during maintenance. Dose escalation or re-treatment with 50 mg obefazimod restored disease control, with approximately 45% achieving clinical remission and nearly 70% achieving clinical response by Week 44. These findings support a dose-escalation strategy for recapturing remission after relapse.
Long‑Term Safety Database Strengthened
The expanded safety analysis included 1,704 patient-years of exposure across the integrated Phase 2 and Phase 3 development program. Exposure-adjusted incidence rates for malignancies, including non-melanoma skin cancer (NMSC), remained within published background rates for patients with ulcerative colitis. Investigators reported no new safety signals, reinforcing the therapy’s favorable long-term benefit-risk profile.
Expanded Evidence Supports FDA Filing
Chief Executive Officer Marc de Garidel said the results broaden the evidence supporting obefazimod across difficult-to-treat ulcerative colitis populations while substantially strengthening the long-term safety database. He noted that the integrated efficacy and safety findings increase confidence as the company prepares its NDA submission later this year.
Remo Panaccione, Professor of Medicine and Director of the IBD Clinic at the University of Calgary, said the consistent efficacy observed in both induction responders and non-responders, together with reassuring long-term safety findings, supports a favorable benefit-risk profile. He added that, if approved, obefazimod could become an important new treatment option for patients with ulcerative colitis.
Robust Phase 3 Findings Drive FDA Submission
The ABTECT Maintenance Part 2 results add to the integrated Phase 3 clinical package supporting Abivax’s planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration in the fourth quarter of 2026. The additional efficacy data in refractory patients and the expanded long-term safety database strengthen the evidence supporting obefazimod as a potential oral treatment for adults with moderate-to-severe ulcerative colitis.
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About the Writer
Shaik Yasmeen (LinkedIn) is a Pharm.D graduate with interests in clinical pharmacy, pharmacovigilance, and medical writing. She has gained experience through hospital clinical postings, patient case reviews, case presentations, and literature evaluation. Passionate about evidence-based healthcare, she is committed to creating accurate and engaging medical content while continuously expanding her professional knowledge.