RYTM - Rhythm Pharma's setmelanotide shows efficacy in obesity study

Rhythm Pharmaceutical (RYTM) gains 9% in premarket, on announcement of positive topline results from Phase 3 trial evaluating setmelanotide, for the treatment of insatiable hunger and severe obesity in individuals with Bardet-Biedl syndrome ((BBS)) or Alström syndromeThe study met primary and secondary endpoints by showing statistically significant and clinically meaningful reductions in weight and hunger scores.11 of 31 or 34.5% of participants achieved the primary endpoint of at least 10% reduction in body weight from baseline at ~52 weeks of therapy.All primary endpoint responders were Bardet-Biedl patients.The company intends to complete regulatory submissions to the FDA and the EMA in 2H of 2021.Setmelanotide activates a protein called melanocortin 4 receptor that plays a key role in controlling appetite.Last month, the FDA approved Imcivree (setmelanotide) for chronic weight management in adult and pediatric patients 6 years of age and older with pro-opiomelanocortin deficiency obesity and leptin receptor deficiency obesity.Earlier in June, the company announced

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Rhythm Pharma's setmelanotide shows efficacy in obesity study