High-dose obefazimod is efficacious in UC regardless of prior therapy exposure

Treatment with obefazimod resulted in significant and clinically meaningful improvements in patients with moderate-to-severe ulcerative colitis (UC), regardless of prior exposure to advanced therapies, according to data from the phase 3 ABTECT-1 and -2 induction trials.

The ABTECT-1 (n=639; NCT05507203) and ABTECT-2 (n=636; NCT05507216) trials randomised patients with moderately-to-severely active UC in a 2:1:1 ratio to receive obefazimod 50 mg, obefazimod 25 mg, or placebo. The primary endpoint was clinical remission at Week 8. Dr Silvio Danese (San Raffaele Hospital, Italy) presented data from a pooled analysis examining treatment response among patients enrolled in ABTECT-1 and -2, stratified by prior inadequate response to advanced therapies. “About 47% of the study population had an inadequate response to a prior advanced therapy, and about 20% had already received a JAK inhibitor,” said Dr Danese [1].

The primary endpoint was met for both the 50 mg group (21% vs 4% with placebo; Δ16%; P<0.0001) and the 25 mg group (18% vs 4%; Δ13%; P<0.0001). Among patients with prior exposure to advanced therapies, the clinical remission rates were 13% (P=0.0009), 7% (P=0.17), and 3% in the 50 mg, 25 mg, and placebo groups, respectively. In contrast, in patients without prior exposure to advanced therapies, the clinical remission rates were 28% and 27% for the 50 mg and 25 mg groups, respectively, both significantly higher than placebo (5%; P<0.0001 for both).

“In general, these results were consistent across other efficacy endpoints,” noted Dr Danese. “We observed a clear dose-response among patients with an inadequate response to prior advanced therapies and comparable efficacy between the two obefazimod doses in treatment-naïve participants.” Obefazimod was well tolerated, and no new safety issues were identified.

In conclusion, obefazimod 50 mg demonstrated clinically meaningful efficacy regardless of prior exposure to advanced therapies. Furthermore, the higher dose appeared to be more effective than the lower dose among patients who had previously received advanced therapies.

1. Danese S, et al. Efficacy of obefazimod in ABTECT phase 3 induction trials: results of 8-week therapy in subsets of patients with and without prior inadequate response to advanced therapies. LB06, Hot off the press: IBD treatment, UEG Week, 4-7 October 2025, Berlin, Germany.

Medical writing support was provided by Robert van den Heuvel.
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Posted on 6 October 2025