Rhythm Pharmaceuticals Announces Comprehensive Expansion of Clinical Development Program with Five New Phase 2 and 3 Trials Planned to Evaluate Setmelanotide in Rare Genetic Diseases of Obesity
Excerpt from the Press Release:
CAMBRIDGE, Mass., Aug. 03, 2021 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today announced a significant expansion of its clinical development program for setmelanotide with five new planned Phase 2 and 3 clinical trials. Rhythm will review these updates on its second quarter 2021 financial results and business update conference call today at 8 a.m. ET.
New trials include the pivotal EMANATE Phase 3 trial and the DAYBREAK Phase 2 trial, which together will evaluate setmelanotide in people with variants in one of 36 genes in the melanocortin-4 receptor (MC4R) pathway. Based on genetic sequencing data and setmelanotide response rates achieved in a phase 2 trial, Rhythm estimates that the five genetic indications being studied in the EMANATE trial represent a potential addressable patient population of approximately 100,000-200,000 people in the United States.
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