Rhythm Pharmaceuticals announces development plan of setmelanotide

Rhythm Pharmaceuticals announced plans to add a cohort of patients with hypothalamic obesity in Japan to its ongoing global Phase 3 clinical trial of setmelanotide, with dosing expected to begin in the third quarter of 2024. “Following constructive discussions with Japan’s Pharmaceuticals and Medical Devices Agency, we are pleased to have developed a clear and efficient plan to support the potential approval of setmelanotide for hypothalamic obesity in Japan,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm. “With data showing a higher per-capita incidence and prevalence of patients with hypothalamic obesity in Japan compared to the United States and Europe and no approved therapeutic options, there is a major unmet need for a therapy to treat the rapid onset of severe obesity and hyperphagia of hypothalamic obesity.” The Company and Japan’s PMDA agreed to add a cohort of 12 Japanese patients to the ongoing trial and, pending completion of the trial, to use these data as part of the Company’s registration package to seek approval from Japan’s Ministry of Health, Labor and Welfare. In addition to efficacy data, Rhythm will collect and submit pharmacokinetics data from Japanese patients, expediting the typical pathway of collecting such data from an earlier-stage trial in Japanese subjects.