Abivax's inflammatory bowel drug meets main goal of late stage trial

Abivax SA

01/06/2026 23:36

       June 1 (Reuters) - Abivax  ABVX.PA  said on Monday its
experimental drug for patients with ulcerative colitis, a type
of chronic inflammatory ​disease, met the main goal of a closely
watched late-stage trial.
    In a 44-week study, 50.8% of patients on the 25 milligram
dose, and about 51.3% on the higher 50 mg dose of the
experimental oral pill, obefazimod, experienced clinical
remission, compared to 10.4% on placebo.
    The compelling results significantly exceeded expectations
and further support the view that the drug is a highly
differentiated late-stage oral therapeutic in inflammatory bowel
disease, said Leerink analyst Thomas Smith.
    Ulcerative colitis causes inflammation and sores, called
ulcers, in the colon.
    Both doses met the main goal, showing placebo-adjusted
clinical remission rates of 39.3% and 40.3% for the 25 mg and 50
mg doses, respectively.
    This represents the best placebo-adjusted clinical remission
rates that have been reported to date in a large UC program,
said Smith.
    U.S.-listed shares of the French company, however, fell more
than 30% in extended trading.
    In the study, there were at least one case each of prostate
cancer, breast cancer and colonic dysplasia in patients taking
the 50 mg dose. The company said the cases were considered
unrelated to treatment by investigators.
    Two cases each of basal cell carcinoma and squamous cell
carcinoma — types of skin cancer — were also reported in
patients taking the higher dose.
    Two of the four 50 mg patients were deemed not or unlikely
related to drug by investigators, the company said. Of the
remaining two cases, one had a medical history of skin cancer.
    Smith said the drug features the most compelling late-stage
clinical profile for a novel oral agent in IBD amid heightened
M&A activity that underscores large pharma's interest in the
space.
    There have been several takeover speculations for the
company.

 (Reporting by Sriparna Roy in Bengaluru; Editing by Shilpi
Majumdar)
 ((Sriparna.Roy@thomsonreuters.com))