BofA warns Fed risks policy mistake with early rate cuts
Investing.com -- Abivax shares rose over 400% in Paris on Wednesday after the French biotech company announced that its lead drug candidate obefazimod achieved primary endpoints in two Phase 3 clinical trials for ulcerative colitis.
According to topline data from the ABTECT-1 (Study 105) and ABTECT-2 (Study 106) trials, obefazimod administered at a 50 mg once-daily dose demonstrated statistically significant clinical remission at Week 8, meeting the primary endpoint in both studies.
The global trials evaluated oral obefazimod at 25 mg or 50 mg once-daily doses in more than 1,200 adults with moderately to severely active ulcerative colitis who had failed to respond, inadequately responded, or become intolerant to conventional and/or advanced therapies.
The Paris-based company reported that all key secondary endpoints were also met with the 50 mg once-daily dose of obefazimod in both studies.
On the safety front, Abivax noted that both doses of the experimental therapy were well tolerated among patients, with no new safety signals identified.
The company plans to file a New Drug Application (NDA) with the FDA in the second half of 2026, pending positive results from a 44-week maintenance trial. Topline data from this maintenance study is expected in the second quarter of 2026.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.