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Bausch Health Announces Positive Topline Results From Global Phase 2 Study Evaluating Amiselimod (an S1P antagonist) to Treat Ulcerative Colitis
Trial Meets Both Primary and Key Secondary Endpoints LAVAL, QC / ACCESSWIRE / December 21, 20...
About this update from Bausch Health Companies Inc.
[{"type":"text","content":"Bausch Health Announces Positive Topline Results From Global Phase 2 Study Evaluating Amiselimod (an S1P antagonist) to Treat Ulcerative ColitisTrial Meets Both Primary and Key Secondary EndpointsLAVAL, QC / ACCESSWIRE / December 21, 2023 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) (\"Bausch Health\" or the \"Company\") today announced positive topline results from the Company's Phase 2 study evaluating Amiselimod, an investigative S1P antagonist, for the treatment of ulcerative colitis (UC).\"We are thrilled with these impressive topline results, and believe that this could offer a much needed improvement in therapy available for patients with ulcerative colitis,\" said Thomas J. Appio, Chief Executive Officer, Bausch Health.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 (0.2 mg QD and 0.4 mg QD).The topline results for the key endpoints were as follows:The primary endpoint, mean change in modified Mayo Score at Day 85 (-2.3) versus placebo (-1.6), (p = 0.002).32.4% of patients on Amiselimod achieved clinical remission, compared to 17.8% on placebo, (p=0.007)42.7% of patients on Amiselimod achieved endoscopic improvement (Mayo endoscopy subscore of ≤ 1), compared to 23.4% on placebo, (p<0.001)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.\"Our R&D team will be presenting detailed results at upcoming medical conferences, and we plan to meet with regulatory agencies to advance the program into Phase 3,\" said Dr. Tage Ramakrishna, Chief Medical Officer, President, R&D, Bausch Health.About AmiselimodAmiselimod is a sphingosine-1-phosphate (S1P) receptor functional antagonist and, by inhibiting the receptor function of the lymphocyte sphingosine-1-phosphate (S1P) receptor, retains lymphocytes sequ...