June 1 (Reuters) – Abivax 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)
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