On October 5, 2025, Abivax SA issued a press release announcing the first of two late‑breaking presentations of its Phase 3 ABTECT 8‑Week Induction Trial results at the United European Gastroenterology (UEG) Meeting in Berlin. The presentation covered data from 1,272 patients enrolled in the ABTECT‑1 and ABTECT‑2 studies and included updated safety information through week 8.
The efficacy data showed that obefazimod met its FDA primary endpoint of clinical remission at week 8 in the 50 mg once‑daily dose. In ABTECT‑1, the placebo‑adjusted remission rate was 19.3 % (p < 0.0001), while in ABTECT‑2 it was 13.4 % (p = 0.0001). All key secondary endpoints, including clinical response, endoscopic and histologic improvement, were also met.
Safety analysis revealed no signal for serious, severe, or opportunistic infections or malignancies. The most common treatment‑emergent adverse events were headache (24.1 % at 50 mg) and nausea (7.2 % at 50 mg), with less than 1 % of headaches leading to discontinuation. No new safety signals were identified.
Abivax will host an investor and analyst conference call on October 6, 2025, at 9:00 a.m. ET to discuss the topline results in detail. The presentation marks a significant milestone in the development of obefazimod and provides a clearer view of its potential regulatory and commercial trajectory.
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