Abivax SA ADR (NASDAQ:ABVX) shares climbed 7.7% in premarket trading Monday after the clinical-stage biotechnology company reported positive Phase 3 results for its experimental ulcerative colitis treatment, obefazimod.
The company said its once-daily 50 mg dose of obefazimod produced clinically meaningful improvements across all key endpoints in patients with moderate-to-severe ulcerative colitis, including those who had previously not responded adequately to advanced therapies.
In the pooled ABTECT 1 and 2 trials, which enrolled 1,272 patients, the 50 mg dose led to significant gains in clinical remission both for participants with and without prior inadequate response to other treatments. Among patients with prior treatment failure, the placebo-adjusted difference was 10% (p=0.0009), while those without previous inadequate response showed a 22% difference.
The data also highlighted robust results in difficult-to-treat populations — including a 29% placebo-adjusted improvement in clinical response among patients who had failed four or more lines of advanced therapy (p=0.0242). For those who had not responded to JAK inhibitors, obefazimod produced a 34% placebo-adjusted improvement (p=0.0017).
Abivax noted that both the 25 mg and 50 mg doses demonstrated similar efficacy in patients who had not previously failed advanced therapy, and both doses were well tolerated, with no new safety issues detected.
Roughly 60% of trial participants had an endoscopic subscore of 3, indicating severe ulcerative colitis, while 47% had a history of inadequate response to prior advanced therapies, including 21% who had failed JAK inhibitor treatment.
The Phase 3 findings were presented at the United European Gastroenterology Meeting held in Berlin, Germany, reinforcing Abivax’s position as a leading innovator in inflammatory bowel disease therapeutics.
This content is for informational purposes only and does not constitute financial, investment, or other professional advice. It should not be considered a recommendation to buy or sell any securities or financial instruments. All investments involve risk, including the potential loss of principal. Past performance is not indicative of future results. You should conduct your own research and consult with a qualified financial advisor before making any investment decisions.