What question did this study set out to answer?

To evaluate the symptomatic improvement achieved by obefazimod in moderately to severely active ulcerative colitis during two Phase 3 trials.

January 23, 2026

P0923Early symptomatic improvement with obefazimod in patients with moderately to severely active ulcerative colitis: pooled results from the ABTECT-1 and ABTECT-2 Phase 3, double-blind, placebo-controlled induction trials

Key Points

To evaluate the symptomatic improvement achieved by obefazimod in moderately to severely active ulcerative colitis during two Phase 3 trials.
Multicenter, randomized, double-blind, placebo-controlled design
Enrollment of patients with moderate-to-severe UC
Randomization to obefazimod at doses of 50 mg QD, 25 mg QD, or placebo
Assessment of symptom improvement from week 1 to week 8
Measurement of changes in stool frequency and rectal bleeding subscores
Both doses of obefazimod showed significant symptom reduction by week 2 compared to placebo
Greater proportions of patients receiving obefazimod achieved reductions in rectal bleeding and stool frequency from week 1
Achievement of symptomatic response and remission was noted by week 2 for obefazimod patients
Improvements continued through week 8, highlighting sustained efficacy.

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 clinical, endoscopic and histologic endpoints. Here, we report the onset of symptomatic improvement with Obe in pts with UC enrolled in ABTECT trials. Methods The multicenter, randomized, double-blind, placebo-controlled ABTECT trials enrolled pts with moderate-to-severe UC (modified Mayo score (MMS)≥ 5, rectal bleeding subscore (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 upper limit), including corticosteroids, immunosuppressants, biologics, S1P receptor modulators and/or JAK inhibitors. Pts were randomized 2:1:1 to Obe 50 mg QD (Obe-50), Obe 25 mg QD (Obe-25) or placebo (PBO). This analysis assessed symptom improvement from W1 through W8, including change from baseline in stool frequency subscore (SFS) and RBS, and the proportion of pts achieving symptomatic response and remission. Results 1272 pts were randomized and treated in ABTECT trials, with balanced baseline characteristics across treatment groups. In this pooled analysis, both Obe-25 and Obe-50 produced reductions in RBS and SFS versus PBO, starting from W1, reaching a nominally significant differentiation from PBO by W2, with symptom improvements consistently increasing through W8. From W1, a greater proportion of pts receiving Obe achieved reductions in RBS ≥1 point and SFS ≥1 point from baseline versus PBO (Table). Greater proportions of pts receiving Obe achieved RBS=0 from W2 at both doses, while achievement of SFS = 0 or 1 occurred by W2 for Obe-50 and by W4 for Obe-25. Greater proportions of pts receiving Obe achieved symptomatic response from W1 and symptomatic remission from W2. Conclusion In the ABTECT induction trials, both Obe doses demonstrated rapid and clinically meaningful symptoms improvement versus PBO, evident as early as W1. 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: Armuzzi, Alessandro: Consulting fees from AbbVie, Abivax, Alfa Sigma, Astra Zeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Eli-Lilly, Enthera, Ferring, Galapagos, Gilead, Giuliani, Janssen, Lionhealth, MSD, Nestlé, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sanofi, Sandoz, Takeda, Teva Pharmaceuticals, Tillots Pharma Speaker’s fees from AbbVie, Abivax, AG Pharma, Alfa Sigma, Biogen, Bristol-Myers Squibb, Celltrion, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, Lionhealth, MSD, Novartis, Pfizer, Roche, Samsung Bioepis, Sandoz, Takeda, Teva Pharmaceuticals Research support from Biogen, MSD, Takeda, and Pfizer Non-financial support from Abbvie, Janssen, MSD, Pfizer, Takeda Atreya, Raja: Personal Fees: AbbVie, Abivax, AstraZeneca, Bristol-Myers Squibb, Celltrion Healthcare, Falk Foundation, Galapagos, Gilead, Johnson&Johnson, Lilly, MSD Sharp & Dohme, Takeda Pharma. Sparrow, Miles P.: Educational grants or research support – Gilead, Celltrion Speaker’s fees – Janssen, Abbvie, Ferring, Takeda, Pfizer, Celltrion, Eli Lilly, Dr. Falk Pharma Advisory boards or consultancy fees – Janssen, Takeda, Pfizer, Celgene, Abbvie, MSD, Emerge Health, Gilead, BMS, Celltrion, Eli Lilly, Alimentiv Markovic, Srdjan: Speaker fees for Abivax Le Berre, Catherine: Abbvie, Amgen, Celltrion, Ferring, Fresenius Kabi, Galapagos, Gielad, Janssen, Lilly, MSD, Nordic Pharma, Pfizer, Sandoz, Takeda. Hlavaty, Tibor: Personal Fees: Pfizer, Abbvie, Takeda, Janssen Pharmaceuticals, Amgen Tretón, Xavier: Personal Fees: Lectures and advisory board : Abbvie, Calltrion, MSD, johnson&Johnson, Takeda, Amgen, Alphasigma, Lilly Other: participations: Thabor Therapeutics Cataldi, Fabio: Employee of Abivax Jacobstein, Doug: Employee of Abivax Rabbat, Chris: Employee of Abivax Shan, Kevin: Employee of Abivax 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

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Armuzzi et al. (Thu,) studied this question.

synapsesocial.com/papers/69731005c8125b09b0d1fbca https://doi.org/https://doi.org/10.1093/ecco-jcc/jjaf231.1104

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