French biotechnology company Abivax has released top-line findings from two phase 3 clinical trials evaluating its oral small molecule candidate, obefazimod, for the treatment of ulcerative colitis.
The two studies, named ABTECT-1 and ABTECT-2, included a combined total of 1,275 participants from various global locations. Both trials compared daily doses of 50 mg and 25 mg obefazimod against placebo. The primary endpoint in each study was the rate of clinical remission after eight weeks, measured by a modified version of the Mayo Score.
According to Abivax, obefazimod achieved a statistically significant pooled remission rate of 16.4% across both studies, broadly meeting the primary endpoints. In the ABTECT-1 study, both the 50 mg and 25 mg treatment groups showed significantly higher remission rates than placebo. However, in ABTECT-2, only the 50 mg group reached a statistically significant difference compared to placebo.
Addressing the differing outcomes, Abivax stated that this may be attributed to the characteristics of the patients assigned to the 25 mg group in ABTECT-2. Fabio Cataldi, M.D., Chief Medical Officer at Abivax, said during a July 22 investor call, “The patient population randomized to the 25-milligram dose in ABTECT-2 was the most difficult to treat population across both ABTECT-1 and ABTECT-2.” He further noted that based on baseline disease characteristics, such patients might require more than eight weeks of treatment to reach clinical remission.
The company reported that the safety profile of obefazimod in the phase 3 trials was in line with prior studies and that no new safety concerns were identified. Headaches were experienced by some participants, a point addressed during the investor call. David Rubin, M.D., gastroenterologist and director of the Inflammatory Bowel Disease Center at the University of Chicago Medicine, stated that the headaches occurred in a small number of patients, fewer than in earlier phase studies, and were short-lived, generally appearing during the first few days or week of treatment and then resolving.
Abivax is conducting a long-term maintenance trial that includes participants from both ABTECT-1 and ABTECT-2. This ongoing study will continue through 2030, with primary completion anticipated in 2026. The company is also testing obefazimod in a separate phase 2 trial targeting Crohn’s disease. Abivax stated in its release that it intends to submit obefazimod for regulatory approval to both the U.S. Food and Drug Administration and the European Medicines Agency in the second half of 2026.
Obefazimod was originally developed as a potential treatment for HIV but was redirected to ulcerative colitis following unsatisfactory results in mid-stage HIV trials. Positive phase 2 data for colitis were announced in 2018. Financially, the company secured an investment from Sofinnova in 2019, which extended its operational capacity into 2020. Additional funds were raised through a European stock sale in 2022 and an initial public offering in 2023.
Despite these efforts, Abivax’s current funding is projected to last only through the fourth quarter of 2025.
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