en.Wedoany.com Reported - Abivax announced positive topline results from the Phase 3 ABTECT maintenance trial of its oral miR-124 enhancer, obefazimod, in patients with moderately to severely active ulcerative colitis (UC). At Week 44, both the 25 mg and 50 mg dose groups met the primary endpoint of clinical remission and all key secondary endpoints.

The ABTECT maintenance trial is a global, 44-week, multicenter, randomized, double-blind, placebo-controlled study evaluating the long-term efficacy and safety of once-daily oral obefazimod at 25 mg and 50 mg doses. A total of 580 participants who achieved clinical response following the 8-week ABTECT-1 and ABTECT-2 induction trials were re-randomized to receive 25 mg obefazimod, 50 mg obefazimod, or placebo. Results showed that at Week 44, the placebo-adjusted clinical remission rate was 39.3% (actual remission rate 50.8%) in the 25 mg group and 40.3% (actual remission rate 51.3%) in the 50 mg group, compared to 10.4% in the placebo group, with p-values <0.0001 for both.

All key secondary endpoints achieved statistical significance in both dose groups. Specific data include: endoscopic improvement, 54.9% in the 25 mg group (placebo-adjusted Δ42.5%) and 64.1% in the 50 mg group (Δ51.0%); endoscopic remission, 41.5% in the 25 mg group (Δ31.4%) and 47.7% in the 50 mg group (Δ37.8%); HEMI, 50.3% in the 25 mg group (Δ39.4%) and 57.4% in the 50 mg group (Δ46.5%); corticosteroid-free clinical remission, 45.1% in the 25 mg group (Δ35.1%) and 47.7% in the 50 mg group (Δ38.0%); sustained clinical remission (achieved at both Week 40 and Week 44), 67.1% in the 25 mg group (Δ52.8%) and 65.6% in the 50 mg group (Δ49.1%).

Obefazimod demonstrated a favorable overall safety profile in this maintenance trial, with no new safety signals identified. The incidence of treatment-emergent adverse events (TEAEs) was 50.0%, 58.0%, and 71.8% in the placebo, 25 mg, and 50 mg groups, respectively. TEAEs leading to drug discontinuation occurred in 6.8%, 2.6%, and 4.6% of patients, respectively. Serious adverse event rates were 4.2%, 2.6%, and 5.6%, respectively. No deaths were reported in any group, and no cases of acute pancreatitis or cardiac abnormalities suggestive of cardiac fibrosis were observed. The incidence of serious infections and opportunistic infections was approximately 1% in each group. Regarding malignancies, one case of prostate cancer, one case of breast cancer, and one case of colonic dysplasia were reported in the 50 mg group, which investigators deemed unrelated to treatment, with no organ-specific clustering observed. For non-melanoma skin cancer (NMSC), one case of basal cell carcinoma was reported in the placebo group; one case of squamous cell carcinoma in the 25 mg group; and two cases of basal cell carcinoma and two cases of squamous cell carcinoma in the 50 mg group. Among the four patients in the 50 mg group, two were considered by investigators to be unrelated or unlikely related to the drug, and one of the remaining two had a history of skin cancer.

Abivax plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for obefazimod in the treatment of ulcerative colitis by the end of the fourth quarter of 2026. Additionally, topline results from a Phase 2b induction trial in Crohn's disease are expected in mid-2027. Previously reported data from a Phase 2a/2b open-label extension study showed durable clinical remission and a favorable safety profile over up to seven years of exposure.

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