Bausch Health: Phase 2 study of Amiselimod meets primary, secondary endpoints

Bausch Health Companies announced topline results from the Company’s Phase 2 study evaluating Amiselimod, an investigative S1P antagonist, for the treatment of ulcerative colitis. Amiselimod met the primary and key secondary endpoints including clinical and endoscopic measures in the double-blind period of the study; the open-label extension up to 52 weeks is currently ongoing. Efficacy results were similar for both dose groups. The topline results for the key endpoints were as follows: The primary endpoint, mean change in modified Mayo Score at Day 85 versus placebo. 32.4% of patients on Amiselimod achieved clinical remission, compared to 17.8% on placebo, 42.7% of patients on Amiselimod achieved endoscopic improvement, compared to 23.4% on placebo, Amiselimod was well-tolerated, with no unexpected adverse events; coupled with the previous thorough QT study, this indicates that Amiselimod has a favorable safety profile. The full data set from this trial will be available early next year. Bausch Health’s Phase 2 clinical trial was a 12-week, double-blind, placebo-controlled, randomized, dose ranging study to evaluate the efficacy and safety of Amiselimod in 320 patients with mildly-to-moderately active UC.