Abivax: Obefazimod Achieves Main Goal in Phase 3 for UC
Abivax announced on Monday positive results from the phase 3 ABTECT maintenance trial evaluating obefazimod in active moderate to severe ulcerative colitis. The two tested doses, 25 mg and 50 mg administered once daily, achieved the primary endpoint of clinical remission at week 44, with adjusted differences versus placebo of 39.3 and 40.3 percentage points, respectively. The release also reports a generally favorable safety profile, while detailing several cases of cancers or precancerous lesions observed in the trial, primarily in the 50 mg group.
Two Doses Meet Main Clinical Remission Criterion
At week 44 of the ABTECT trial, obefazimod met the primary evaluation criterion in both dosages studied. The 25 mg dose achieved a clinical remission rate of 50.8%, compared to 10.4% under placebo, representing an adjusted difference of 39.3 percentage points. The 50 mg dose recorded a clinical remission rate of 51.3%, also against 10.4% under placebo, corresponding to an adjusted difference of 40.3 percentage points. In both cases, the differences were statistically significant.
A Global Maintenance Study in Ulcerative Colitis
The ABTECT maintenance trial is a global phase 3, multicenter, randomized, double-blind, placebo-controlled study. It evaluated the long-term efficacy and safety of obefazimod in adults with active moderate to severe ulcerative colitis. Participants, who responded after the ABTECT-1 and ABTECT-2 induction trials, were re-randomized to receive either 25 mg of obefazimod, 50 mg of obefazimod, or a placebo.
Secondary Endpoints Also Met
Abivax reports that both doses of obefazimod also met all the main secondary endpoints, including endoscopic improvement, endoscopic remission, histologic-endoscopic mucosal improvement, clinical remission without corticosteroids, and sustained clinical remission. For endoscopic improvement, the rates were 54.9% with 25 mg and 64.1% with 50 mg, compared to 12.5% under placebo. For endoscopic remission, the rates reached 41.5% and 47.7%, compared to 9.9% under placebo.
