Abivax SA (ABVX) said its Phase 3 maintenance trial evaluating obefazimod in adults with moderately to severely active ulcerative colitis met its primary endpoint
Both the 25 mg and 50 mg doses also met all key secondary endpoints, including endoscopic improvement, endoscopic remission, corticosteroid-free clinical remission and sustained clinical remission, the company said Monday in a statement.
Obefazimod demonstrated a favorable safety profile over the 44-week maintenance trial, with no new safety signals observed, the company said.
Week-44 clinical remission rates were 50.8% with 25 mg and 51.3% with 50 mg, versus 10.4% for placebo, the company said.
Abivax plans to submit a New Drug Application to the US Food and Drug Administration in Q4.
Abivax shares fell 23% in after-hours trading.