What question did this study set out to answer?

Evaluate the impact of age on the efficacy and safety of obefazimod in patients with ulcerative colitis in two Phase 3 trials.

January 23, 2026

P1048Impact of age of subjects on the efficacy and safety of once-daily oral obefazimod in moderately to severely active ulcerative colitis: week 8 results from the ABTECT-1 and ABTECT-2 Phase 3, double-blind, placebo-controlled induction trials

Key Points

Evaluate the impact of age on the efficacy and safety of obefazimod in patients with ulcerative colitis in two Phase 3 trials.
Conducted two multicenter, randomized, double-blind, placebo-controlled trials (ABTECT-1 and ABTECT-2).
Enrolled patients aged <65 years and ≥65 years with moderate to severe ulcerative colitis.
Randomized patients to receive either obefazimod 50 mg, 25 mg, or placebo for 8 weeks.
Assessed clinical remission, endoscopic improvement, and adverse events.
Conducted a post-hoc analysis grouped by age categories.
Obefazimod showed a higher percentage of patients achieving clinical remission compared to placebo in all age groups.
Among those <65 years, remission rates were 16.2% higher for Obe-50 and 12.1% for Obe-25 compared to placebo.
In patients ≥65 years, the remission rates increased by 14.6% for Obe-50 and 24.9% for Obe-25.
59.8% of patients <65 years experienced treatment emergent adverse events (TEAEs) with Obe-50, while the rate for ≥65 years was 65.9%.
No new safety concerns emerged across age subgroups.

Abstract

Abstract Background Obefazimod (Obe) is an oral, once-daily (QD), small molecule which enhances expression of microRNA-124 and shows efficacy in patients (pts) with moderately to severely active ulcerative colitis (UC) 1-3. In Phase 3 ABTECT-1 NCT05507203 and ABTECT-2 NCT05507216 8-week induction trials, Obe achieved clinically meaningful improvements in clinical, endoscopic and histologic endpoints. Considering the UC is more commonly seen in the older population and studies are needed in this pt group, we evaluate the impact of age on efficacy and safety of Obe in pts with UC enrolled in ABTECT trials. Methods The two 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 (no upper limit) . 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, pts were categorized by age: 65 years old (yo), ≥65 yo, median of 41 yo or ≤median of 41 yo. Efficacy endpoints included clinical remission/response, endoscopic improvement/remission, symptomatic remission, and histo-endoscopic mucosal improvement (HEMI). All p-values are nominal. Treatment emergent adverse events (TEAEs), serious TEAEs and study discontinuation rates were examined. Results Among the 1272 randomized and treated pts in ABTECT trials, 1183 were 65 yo and 89 were ≥65 yo; by median age, 606 pts were 41 yo and 666 pts were ≤41 yo. In both trials, baseline demographics and disease characteristics were generally similar between treatment groups, regardless of age group. In a pooled analysis, a higher proportion of pts receiving Obe-25 or Obe-50 versus PBO achieved clinical remission across age subgroups (Obe-50-PBO difference: pts 65 yo: 16.2%; ≥65 yo: 14.6%; Obe-25-PBO difference: 65 yo: 12.1%; ≥65 yo: 24.9%) and met most clinical and endoscopic endpoints across age subgroups with nominal significance (Table). Among pts 65 yo, TEAEs occurred in 59.8%, 49.5%, and 50.3% of those receiving Obe-50, Obe-25, and PBO, respectively. For patients ≥65 yo, rates were 65.9%, 38.9%, and 55.6%. Headache was the most frequent TEAE when treated with Obe across all age groups. Overall rates of serious TEAEs and TEAEs leading to study drug discontinuation were similar between Obe and PBO. No signal was observed for serious, severe, or opportunistic infections or malignancies. Conclusion In both ABTECT induction trials, obefazimod demonstrated consistent efficacy and safety across age subgroups with no new or unexpected safety findings. 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 Conflict of interest: Magro, Fernando: Fernando Magro served as speaker and received honoraria from Abbvie, Arena, Biogen, Bristol-Myers Squibb, Falk, Ferring, Hospira, Janssen, Laboratórios Vitoria, Pfizer, Lilly, Merck Sharp & Dohme, Sandoz, Takeda, UCB, Vifor. Tilg, Herbert: Consultant for Abivax Cataldi, Fabio: Employee of Abivax Jacobstein, Doug: Employee of Abivax Rabbat, Chris: Employee of Abivax Shan, Kevin: Employee of Abivax Nancey, Stéphane: board membership and lecturing fees from Abbvie, Takeda, Celltrion Healthcare, Pfizer, Galapagos, Johnson & Jonshon, Lilly, Fresenius, Amgen, Medac, MSD. Markovic, Srdjan: Speaker fees for Abivax Rocco, Rodrigo: Speaker for AbbVie, Abivax, and Janssen. Advisory Board Member for Janssen. Research Grants / Study Support from AbbVie, Abivax, Alexion, AstraZeneca, Eli Lilly, Janssen, Mirador, Spytherapeutics, Ventix, and Xelcor. Congress and Educational Support from AbbVie, Abivax, and Janssen. Harlacher, Luciana: Speaker fee from Johnson & Johnson, AbbVie, and Takeda. Conducts clinical trials for Johnson & Johnson, AbbVie, Takeda, Ventyx, Abivax, BMS, Lilly, MSD, and Sanofi. Yarur, Andres: Personal Fees: Consultant for Takeda, Pfizer, Roche, Merck, Abbvie, Eli Lilly. Bristol Myers Squibb, Celltrion, Johnson and Johnson.

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