Two pivotal Phase III studies evaluating RM 493 in POMC and LEPR published in The Lancet Diabetes & Endocrinology.- Rhythm Pharma

Rhythm Pharmaceuticals announced that results from two pivotal Phase III studies evaluating RM 493 (setmelanotide) in proopiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity were published in The Lancet Diabetes & Endocrinology. As previously reported, data from the studies demonstrate that treatment with setmelanotide, the company’s melanocortin-4 receptor (MC4R) agonist, led to statistically significant and clinically meaningful reductions of weight and hunger. Eight of 10 participants with POMC deficiency obesity (80%; P<0.0001 compared with historical data) and five of 11 participants with lepr deficiency obesity (45%; p="0.0001" compared with historical data) achieved at least 10 percent weight loss at approximately one year. the mean percent change in “most hunger” score in participants aged 12 years and older was -27.1 percent (n="7;" p="0.0005)" in pomc deficiency obesity and -43.7 percent (n="7;" p><0.0001) in lepr deficiency obesity. consistent with prior clinical experience, setmelanotide was generally well-tolerated in both trials. the most common adverse events were injection site reaction, skin hyperpigmentation, and nausea. rhythm initially reported positive topline data from the phase iii studies in august 2019 and subsequently presented updated data in a late-breaking research forum during the 37th annual meeting of the obesity society at obesity week 2019.see: "efficacy and safety of setmelanotide, an mc4r agonist, in individuals with severe obesity due to lepr or pomc deficiency: single-arm, open-label, multicentre, phase 3 trials." karine clément et al. the lancet diabetes & endocrinology:october 30, 2020 doi:https: doi.org 10.1016 s2213-8587(20)30364-8>