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Rhythm Pharmaceuticals Announces Publication of Results from Phase 2 Study of Setmelanotide in Bardet-Biedl Syndrome in Diabetes, Obesity and Metabolism
-- Study demonstrated that treatment with setmelanotide reduced body weight and hunger in individuals living with Bardet-Biedl syndrome -- BOSTON, July 16,
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- Study demonstrated that treatment with setmelanotide reduced body weight and hunger in individuals living with Bardet-Biedl syndrome --\n BOSTON, July 16, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, announced today that results from its Phase 2 study evaluating setmelanotide for the treatment of obesity and insatiable hunger, known as hyperphagia, in patients living with Bardet-Biedl Syndrome (BBS) were published in the peer-reviewed journal Diabetes, Obesity and Metabolism. As previously reported, data from the study demonstrate that treatment with setmelanotide, the company’s melanocortin-4 receptor (MC4R) agonist, reduced body weight and hunger in individuals with BBS. “Treatment with setmelanotide demonstrated a substantial reduction in body weight and hunger, making this the first-ever Phase 2 study of any investigational pharmacologic agent to show positive results for the treatment of obesity and hunger in individuals living with BBS,” said Robert M Haws, M.D., Director of the Clinical Research Center at the Marshfield Clinic Research Institute. “These findings also suggest that obesity and hyperphagia associated with BBS have ties to impaired signaling of the MC4R pathway and support further evaluation of MC4R activation as a potential treatment option.” Rhythm initially reported topline data from its Phase 2 Basket Study of setmelanotide in BBS in June 2018 and most recently, in September 2019, Rhythm announced updated data following approximately two years on therapy. The Phase 2 study participants received a daily subcutaneous injection of setmelanotide. The dose was titrated every two weeks for up to 12 weeks to establish the individual dose. The primary outcome was mean percent change from baseline in body weight at three months. Mean percent change in body weight was also assessed after six and 12 months of treatment as additional exploratory efficacy outcomes. Change in hunger scores, metabolic parameters, and safety were secondary outcomes. “BBS is a complex disorder, and as the authors of this paper noted, there remains a crucial lack of clinical trials investigating obesity or hyperphagia treatment options in this population,” said Murray St...