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Rhythm Pharmaceuticals Announces Publication of Results from Phase 3 Clinical Trial of IMCIVREE® (setmelanotide) in Bardet-Biedl Syndrome in The Lancet Diabetes and Endocrinology
-- Previously disclosed data demonstrated statistically significant and clinically meaningful reductions in weight and hunger in patients with Bardet-Biedl
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- Previously disclosed data demonstrated statistically significant and clinically meaningful reductions in weight and hunger in patients with Bardet-Biedl syndrome -- BOSTON, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases, today announced that previously disclosed results from a Phase 3 clinical trial that evaluated IMCIVREE® (setmelanotide), an MC4R agonist, in patients with Bardet-Biedl syndrome (BBS) have been published in the peer-reviewed journal The Lancet Diabetes and Endocrinology. The trial met its primary endpoint and all key secondary endpoints, with statistically significant reductions in weight and hunger at 52 weeks on therapy. “Hyperphagia, which is a pathological hunger, and early-onset, severe obesity place a significant burden on both patients living with BBS and their families,” said Prof. Andrea M. Haqq, M.D., Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta. “The results from this pivotal Phase 3 clinical trial – the largest and longest interventional study ever conducted in BBS – showed patients with BBS achieved clinically significant weight loss, reductions in hunger and improvements in health-related quality of life, all of which are highly meaningful to patients with BBS and their caregivers.” Based on these pivotal Phase 3 data, IMCIVREE was approved as the first therapy for chronic weight management in adult and pediatric patients 6 years of age and older with BBS in the U.S. and European Union (EU). BBS is a rare genetic disease that affects approximately 1,500-2,500 people in the U.S. and 2,500 people in the EU and United Kingdom (UK). People living with BBS may experience insatiable hunger, also known as hyperphagia, and severe obesity beginning early in life. BBS may also be associated with cognitive impairment, polydactyly, renal dysfunction, hypogonadism and visual impairment. Rhythm’s multicenter Phase 3 trial (NCT03746522) enrolled patients ≥6 years old with obesity and BBS or Alström syndrome (N=38). Patients were randomized 1:1 to receive up to 3mg of daily subcutaneous setmelanotide or placebo in a 14-week double-b...