Introduction: Bristol-Myers Squibb announced interim results from the True North open-label extension study, strengthening data supporting the treatment of ozanimod in patients with moderately to severely active ulcerative colitis.
On February 17, 2022, Bristol-Myers Squibb announced interim results from the True North open-label extension study, which evaluated the long-term efficacy and safety of Zeposia (ozanimod) in patients with moderately to severely active ulcerative colitis (UC). The study results showed that the proportion of patients achieving clinical remission, clinical response, endoscopic improvement and corticosteroid-free response remained unchanged through week 142. No new safety signals emerged in this study.
Dr. Silvio Danese, Director of the Department of Gastroenterology and Endoscopy at San Raffaele Hospital and Vita-Salute San Raffaele University in Milan, said: "For clinicians treating this serious chronic disease, the results from the True North extension study provide an understanding of long-term treatment outcomes and help identify appropriate treatments for patients with ulcerative colitis. These findings demonstrate the significance of treatment response across multiple key endpoints and build on our current knowledge of the efficacy and safety of ozanimod."
In the True North extension study, interim analysis data from subjects who had previously participated in the Phase 3 True North Zeposia clinical trial (n=823) were examined. At weeks 46, 94 and 142, 45% (203/452), 51% (109/213) and 45% (39/87) of subjects achieved clinical remission; 80% (352/441), 84% (176/209) and 86% (73/85) of subjects achieved clinical response. Among patients who entered the long-term study as responders on day 1, the efficacy of ozanimod was better than that of the overall population. At weeks 46 and 94, 70% (107/152) and 69% (42/61) of patients achieved clinical remission; 95% (145/152) and 98% (60/61) of patients achieved clinical response, respectively. At the time of this analysis, 823 patients in the Phase 3 True North trial entered the open-label extension study, with 64% completing Week 46, 34% completing Week 94, and 14% completing Week 142. The most common reason for discontinuation was poor treatment efficacy (21%). Among 1,158 patients in the pooled population (including patients in the Phase 2 Touchstone study and the Phase 3 True North study), no new safety signals were identified with long-term use of ozanimod.
Jonathan, Senior Vice President, Immunology and Fibrosis Development, Bristol-Myers Squibb "These data strengthen the evidence demonstrating the long-term efficacy and safety of ozanimod, making it an important treatment option prior to treatment with biologic and Janus kinase inhibitors in patients with moderately to severely active ulcerative colitis," said Dr. Sadeh. "With our legacy in translational science for immune-mediated diseases, and our commitment to inflammatory bowel disease research, we are pursuing solutions that can redefine treatment outcomes and improve the standard of care for patients with gastroenterology."
Ozamod is a second-generation oral selective sphingosine 1-phosphate (S1P) receptor modulator that can selectively bind to S1PR1 and S1PR5 receptor subtypes. It can reduce the number of lymphocytes in the blood and lymph circulation, reduce the inflammatory response of the central nervous system, and reduce possible side effects. In March 2020, the U.S. FDA approved Ozamod for the treatment of relapsing multiple sclerosis (RMS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. In November 2021, the European Union approved Ozamod for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, no response, or intolerance to conventional therapies or biologics.
Reference materials: FDA instructions were updated on August 30, 2024. FDA instructions website: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209899
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