Rhythm announced today the initiation of a Phase 2 clinical trial with RM-493, the company's novel melanocortin 4 receptor (MC4R) agonist, for the treatment of obesity.
"This Phase 2 study will greatly expand our understanding of RM-493's profile for the treatment of obesity," said Liz Stoner , MD, Chief Development Officer of Rhythm. "Based on the data from preclinical studies and early clinical trials, we believe RM-493 has substantial therapeutic potential for reducing body weight and insulin resistance in obese and diabetic patients."
The Phase 2 trial is designed to evaluate the effect of RM-493 on weight loss and safety in obese subjects treated for three months. The trial will also assess the drug's effects on glucose and insulin resistance. In 2012, Rhythm completed Phase 1 clinical trials with RM-493 in which obese subjects were treated for up to 28 days. These studies evaluated RM-493's safety, pharmacokinetics, and effect on body weight. Extensive preclinical studies in obese primates preceded these human clinical trials; primates treated for eight weeks lost an average of 13.5% of their body weight, with significant improvements in both insulin sensitivity and cardiovascular function.
"We have seen compelling preclinical and clinical results with RM-493 to date," said Keith Gottesdiener , MD, CEO of Rhythm. "RM-493's potential for double-digit-percent weight loss, its promising initial cardiovascular safety profile, and the improving regulatory climate for obesity drug development present a unique and exciting opportunity to improve the treatment of obesity and diabetes."