Rhythm Metabolic awarded FDA grant to advance ongoing setmelanotide clinical trial in Prader-Willi syndrome

Rhythm announced today the award of a $1 million research grant from the FDA Office of Orphan Products Development to its subsidiary, Rhythm Metabolic, Inc., to support the ongoing Phase 2 clinical trial of setmelanotide, the company's novel peptide MC4 agonist, for the treatment of obesity and hyperphagia in Prader-Willi syndrome (PWS).

The ongoing Phase 2 clinical trial is designed to evaluate the effects of setmelanotide on weight reduction and PWS-specific food-related behavior in obese patients with PWS. This randomized, double-blind, placebo-controlled study is evaluating the safety and efficacy of setmelanotide administered once daily by subcutaneous injection for up to 10 weeks of treatment. The trial will enroll approximately 36 obese patients with PWS.

"We are extremely grateful for this grant from the FDA Office of Orphan Products Development and the important support of the Foundation for Prader-Willi Research in making it happen," said Keith Gottesdiener, MD, CEO of Rhythm. "This grant is meaningful and substantive to advance our ongoing setmelanotide program for the treatment of Prader-Willi."

"The Foundation for Prader-Willi Research is thrilled to have contributed to this amazing effort, bringing the patient voice to the proposal," stated Theresa Strong, Director of Research Programs for FPWR. "We are grateful for the work of Dr. Keith Gottesdiener, CEO of Rhythm and his team, as well as the investigators at the clinical trial sites -- Dr. Jennifer Miller and Elizabeth Roof -- and we look forward to seeing this drug evaluated in Prader-Willi syndrome."