
Obefazimod Data Across Phase 3 and Long-Term Studies to Be Presented at UEG Week 2026
Key Takeaways
- Phase 3 ABTECT-Maintenance will report 44-week efficacy and safety of obefazimod in moderately to severely active UC using a randomized, double-blind, placebo-controlled design.
- Subset analyses will compare 44-week maintenance outcomes between patients with versus without prior inadequate response to advanced therapies, informing positioning in treatment-experienced populations.
Seven presentations will highlight phase 3 maintenance and induction findings, 3-year phase 2 data, and preclinical research evaluating obefazimod in ulcerative colitis.
New clinical and preclinical data evaluating obefazimod in moderately to severely active ulcerative colitis (UC) will be presented at United European Gastroenterology (UEG) Week 2026, held October 17 to 20 in Barcelona, Spain.
The scientific program includes 7 presentations, 4 oral presentations and 3 posters, spanning the phase 3 ABTECT Maintenance and Induction programs, long-term findings from the phase 2 clinical program, and preclinical investigations of obefazimod's effects on inflammation, fibrosis, and tumor burden.
Obefazimod (ABX464) is an investigational therapy currently in phase 3 development for moderately to severely active UC.
Phase 3 Maintenance Findings
Among the featured presentations are results from the 44-week, randomized, double-blind, placebo-controlled phase 3 ABTECT-Maintenance trial evaluating the efficacy and safety of obefazimod in patients with moderately to severely active UC.
Bruce E. Sands, MD, MS, professor of medicine at the Icahn School of Medicine at Mount Sinai, will present the findings during the Hot Topics in Clinical GI Research session on October 19.
A separate oral presentation will examine efficacy after 44 weeks of maintenance therapy according to patients' previous response to advanced therapies. That analysis will be presented by Silvio Danese, MD, PhD, and will compare outcomes among patients with and without a prior inadequate response to advanced treatment.
Long-Term Outcomes Through 3 Years
Long-term phase 2 findings will provide additional insight into the durability of obefazimod treatment.
An oral presentation will report a 3-year interim analysis of efficacy and treatment persistence among patients completing week 144 after dose de-escalation to obefazimod 25 mg. Outcomes will also be stratified according to patients' prior advanced therapy experience.
A related moderated poster will evaluate the efficacy, persistence, and safety of obefazimod through 3 years following dose de-escalation to 25 mg in the open-label phase 2 maintenance study.
Patient-Reported Symptoms in Phase 3
Additional phase 3 data will examine symptoms that can substantially affect patients with UC.
Pooled findings from the 8-week ABTECT phase 3 induction trials will assess the relationship between improvements in bowel urgency and nocturnal bowel movements and improvements in clinical outcomes among patients treated with obefazimod.
David T. Rubin, MD, professor of medicine and chief of gastroenterology, hepatology and nutrition at the University of Chicago, will present the analysis as a moderated poster on October 18.
Exploring Inflammation and Fibrosis
The UEG Week program will also include research examining the potential biological effects of obefazimod beyond clinical efficacy endpoints.
Danese will present preclinical findings evaluating obefazimod's effects on microRNA-124 (miR-124) expression and the modulation of inflammation and fibrosis across preclinical models.
A separate ePoster will examine the therapy's effect on inflammation-driven tumor burden in a murine model of colitis-associated cancer. These findings are preclinical and therefore do not establish an anticancer effect in patients.
Together, the presentations are expected to provide additional evidence regarding obefazimod across induction, maintenance, and long-term treatment, while further exploring its mechanism and potential effects on inflammation and fibrosis.
References
- Sands BE. Efficacy and safety of obefazimod in patients with moderately to severely active ulcerative colitis: Results from the phase 3, randomized, double-blind, placebo-controlled, 44-week maintenance trial (ABTECT-Maintenance). Presented at: United European Gastroenterology Week 2026; October 17-20, 2026; Barcelona, Spain. Abstract OP097.
- Sands BE. Long-term efficacy and persistence with obefazimod after dose de-escalation to 25 mg: 3-year interim analysis in patients with moderately to severely active ulcerative colitis completing Week 144, stratified by prior advanced therapy experience: Results from the Phase 2 program. Presented at: UEG Week 2026; October 17-20, 2026; Barcelona, Spain. Abstract OP107.
- Danese S. Efficacy of obefazimod in Phase 3 ABTECT-Maintenance trial: Results of 44-week therapy in subsets of patients with and without prior inadequate response to advanced therapies. Presented at: UEG Week 2026; October 17-20, 2026; Barcelona, Spain. Abstract OP260.
- Rubin DT. Symptoms of bowel urgency and nocturnal bowel movements are linked with improvement in clinical outcomes among patients with moderately to severely active ulcerative colitis treated with obefazimod: Pooled results from the 8-week ABTECT Phase 3 induction trials. Presented at: UEG Week 2026; October 17-20, 2026; Barcelona, Spain. Abstract MP0296.
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