Rhythm announces additional data from Phase 3 trial of setmelanotide

Rhythm Pharmaceuticals (RYTM) announced additional data from its global Phase 3 TRANSCEND trial of setmelanotide in patients with acquired hypothalamic obesity. This new data set includes 12 patients from a Japanese cohort and 10 supplemental patients who were enrolled in addition to the primary 120-patient pivotal cohort. Highlights from these 52-week data include: -18.8% placebo-adjusted difference1 in BMI reduction; Primary endpoint of mean BMI reduction of -16.4% from baseline for all patients on setmelanotide therapy compared with +2.4% BMI change for patients on placebo at 52 weeks; and among patients aged 12 and older, the setmelanotide group showed an average weekly reduction of 2.5 points in the weekly average most hunger score, compared with a 1.3-point reduction in the placebo group.