Rhythm Pharmaceuticals announces two Phase 3 setmelanotide trials meet endpoints
Rhythm Pharmaceuticals announced additional data from its two pivotal Phase 3 clinical trials evaluating setmelanotide for the treatment of pro-opiomelanocortin, or POMC, deficiency obesity and leptin receptor, or LEPR, deficiency obesity showing the effect of setmelanotide on body mass index, or BMI, scores and certain cardiovascular parameters. These data are being presented by study investigators in a special, late-breaking research forum during the annual meeting of The Obesity Society at ObesityWeek, Rhythm announced that both Phase 3 clinical trials of setmelanotide met their primary endpoints and all key secondary endpoints, demonstrating a statistically significant and clinically meaningful effect on weight loss and reductions in insatiable hunger, or hyperphagia, in patients with POMC deficiency obesity and LEPR deficiency obesity over the course of one year on setmelanotide treatment. Data from both trials also show that when patients withdrew from setmelanotide during a four-week placebo withdrawal period, they experienced rapid increases in weight and hunger. Setmelanotide is a melanocortin-4 receptor, or MC4R, agonist designed to target impairments in the central melanocortin pathway, which is known to regulate weight and hunger. This week's presentations include new data showing the effect of setmelanotide on BMI scores for patients older than 19 and BMI z-scores for patients younger than 19, and its effect on vital signs including diastolic blood pressure, systolic blood pressure and heart rate. Additional analyses of safety data from the Phase 3 trials in POMC deficiency obesity and and LEPR deficiency obesity continue to support that setmelanotide is generally well-tolerated.