Rhythm Pharma's setmelanotide shows efficacy in obesity study

 

• Rhythm Pharmaceutical (NASDAQ: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 syndrome
• The 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 interim Phase 2 data from obese volunteers, that demonstrated weekly setmelanotide administration showed weight loss efficacy, compared to daily treatment.
• https://seekingalpha.com/news/3646550-rhythm-pharmas-setmelanotide-shows-efficacy-in-obesity-study