What question did this study set out to answer?

This research aims to evaluate how baseline body mass index (BMI) influences the efficacy of obefazimod in patients with ulcerative colitis.

January 23, 2026

P1077Impact of baseline body mass index (BMI) on efficacy of obefazimod in patients with moderately to severely active ulcerative colitis: results from the Phase 3 ABTECT induction trials

Key Result

Obefazimod achieved clinical remission in 15.9% of patients with BMI<25, 18.1% with 25≤BMI<30, and 14.5% with BMI≥30, all significantly better than placebo.

Key Points

This research aims to evaluate how baseline body mass index (BMI) influences the efficacy of obefazimod in patients with ulcerative colitis.
Conducted multicenter, randomized, double-blind, placebo-controlled Phase 3 trials (ABTECT-1 and ABTECT-2).
Enrolled patients with moderate-to-severe ulcerative colitis based on modified Mayo scores.
Categorized patients by baseline BMI (<25, 25 to <30, ≥30 kg/m²) for post-hoc analysis.
Administered obefazimod (50 mg or 25 mg) or placebo for 8 weeks, tracking various efficacy endpoints.
Of 1272 patients treated, significant clinical remission was observed in those receiving obefazimod regardless of BMI category.
Obe-50 showed 15.9% improvement in BMI<25, 18.1% in BMI 25 to <30, and 14.5% in BMI≥30 versus placebo.
Obe-25 showed similar remission rates of 13.3%, 11.3%, and 19.2% respectively across BMI categories.

Structured PICO

Does obefazimod improve clinical remission in patients with moderate-to-severe ulcerative colitis irrespective of baseline BMI?

Population

1,272 randomized and treated patients with moderate-to-severe ulcerative colitis (modified Mayo score ≥ 5, rectal bleeding sub-score ≥ 1, centrally read endoscopic score ≥2) who had inadequate response, loss of response, or intolerance to at least one prior therapy.

Intervention

Obefazimod 50 mg or 25 mg oral once daily for 8 weeks

Comparator

Placebo for 8 weeks

Outcome

Clinical remission (per modified Mayo score) at 8 weekscomposite

Obefazimod demonstrated clinically meaningful improvements in clinical and endoscopic endpoints at week 8 in patients with moderate-to-severe ulcerative colitis, irrespective of baseline BMI.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

Abstract Background Obefazimod (Obe) is an oral, once-daily (QD), small molecule which enhances expression of microRNA-124 and has been studied in two Phase 2 induction trials and subsequent open-label maintenance studies 1-3 in patients (pts) with moderately to severely active ulcerative colitis (UC). In Phase 3 ABTECT-1 NCT05507203 and ABTECT-2 NCT05507216 8-week induction trials, Obe achieved clinically meaningful improvements in all clinical, endoscopic and histologic endpoints. Elevated baseline body mass index (BMI) has been associated with a higher risk of treatment failure and suboptimal response to biologic therapy in pts with UC 4. Here, we report the impact of baseline BMI on efficacy of Obe in pts with UC enrolled in Phase 3 ABTECT trials. Methods The multicenter, randomized, double-blind, placebo-controlled ABTECT trials enrolled pts with moderate-to-severe UC (modified Mayo score (MMS)≥ 5, with rectal bleeding sub-score (RBS) ≥ 1 and centrally read endoscopic score ≥2) who had inadequate response, loss of response, or intolerance to at least one prior therapy with no limit on the number of prior advanced therapy inadequate responses . Pts were randomized 2:1:1 to Obe 50 mg QD (Obe-50), Obe 25 mg QD (Obe-25) or placebo (PBO) for 8 weeks. In this post-hoc analysis (all p-values are nominal), pts were categorized based on BMI at baseline (25, 25≥ to 30, and ≥30 kg/m2). Efficacy endpoints evaluated included clinical remission (per MMS), clinical response, endoscopic improvement/remission, symptomatic response/remission, and histo-endoscopic mucosal improvement (HEMI). Results Among the 1272 randomized and treated pts in the ABTECT trials, 740 had a BMI25, 356 had a BMI≥25 to 30, and 173 had a BMI≥30 at baseline. In both trials, baseline demographics and disease characteristics were overall comparable across treatment groups, irrespective of baseline BMI. In the pooled analysis, greater proportions of pts receiving Obe-25 or Obe-50 versus PBO achieved clinical remission with similar effect sizes regardless of baseline BMI (Obe-50-PBO difference: pts with BMI25: 15.9%, p 0.0001; pts with 25≥ BMI 30: 18.1%, p 0.0001; pts with BMI≥30: 14.5%, p = 0.0178; Obe-25-PBO difference: pts with BMI25: 13.3%, p = 0.0001; pts with 25≤ BMI 30: 11.3%, p = 0.0047; pts with BMI≥30: 19.2%, p = 0.0027). Similar results were observed with all other efficacy endpoints evaluated (Table). Conclusion In both ABTECT induction trials, Obe-25 and Obe-50 demonstrated clinically meaningful improvements in clinical, endoscopic, symptomatic, and combined endoscopic-histologic endpoints at week 8, with similar effect sizes, irrespective of baseline BMI. References: 1. Vermeire S, et al. J Crohns Colitis. 2023; 17: 1689-1697 2. Vermeire S, et al. Gastroenterology 2021; 160: 2595-2598 3. Vermeire S, et al. The Lancet Gastroenterology 7: 1024-1035 4. Kurnool S, et al. Aliment Pharmacol Ther. 2018;47:1472–1479 Conflict of interest: Rubin, David T.: Grant support: Takeda Pharmaceuticals Consultant: Abbvie, Abivax SA, Altrubio, Athos Therapeutics, Inc, Bristol-Myers Squibb, Celltrion, Connect BioPharma, Eli Lilly & Co., Genentech (Roche) Inc., Iterative Health, Janssen Pharmaceuticals, Johnson & Johnson, Merck & Co., Mirador, Odyssey Therapeutics, Pfizer, Sanofi, Spyre, Takeda Pharmaceuticals, Vedanta Biosciences, and Ventyx. Dubinsky, Marla C: Personal Fees: Consultant or Advisory Board: Abbvie, Abivax, Astra Zeneca, BMS, Celltrion, Gilead, Genentech, Janssen, Johnson and Johnson, Lilly, Merck, Pfizer, Prometheus Biosciences, Sanofi, Spyre, Target RWE, Takeda Other: Shareholder, Co-founder, Board of Directors of Trellus Health Co-Founder Mi Test Health Scaldaferri, Franco: Consultancy fee/board for Janseen, Takeda, Pfizer, MSD, Sandoz, Galapagos, Celltrion, Ferring, Abbvie, Lilly, Alfasigma, Abivax Cataldi, Fabio: Employee of Abivax Jacobstein, Doug: Employee of Abivax Rabbat, Chris: Employee of Abivax Shan, Kevin: Employee of Abivax Ramos Junior, Odery: No conflict of interest Leoshyk, Oleksii: No conflict of interest de Sa Rolim, Alexander: No conflict of interest Bouhnik, Yoram: Consultant for Abbvie, Alimentiv, Amgen, Biogen, Boehringer Ingelheim, Celltrion, Eli Lilly, Fresenius Kabi, Galapagos, Gilead, Hospira, Iterative Health, Janssen, Mayoli Spindler, Merck, MSD, Norgine, Pfizer, Roche, Sandoz, Sanofi, Takeda, UCB, Lectures from Abbvie, Celltrion, Fresenius Kabi, Galapagos, Gilead, Janssen, Lilly, MSD, Pfizer, Takeda Grant support from Abbvie, Amgen, Fresenius Kabi, Janssen, Takeda, Viatris. Hospitalities from NORDIC PHARMA Abbvie, Alimentiv, Amgen, Biogen, Celltrion, Eli Lilly, Ferring, Fresenius Kabi, Galapagos, Janssen, Mayoli Spindler, MSD, Pfizer, Sandoz, Sanofi, Takeda, Viatris. Atreya, Raja: Personal Fees: AbbVie, Abivax, AstraZeneca, Bristol-Myers Squibb, Celltrion Healthcare, Falk Foundation, Galapagos, Gilead, Johnson&Johnson, Lilly, MSD Sharp & Dohme, Takeda Pharma.

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