Thinly traded Rhythm Pharmaceuticals (NASDAQ:RYTM) is up 38% premarket on increased volume following its announcement of positive results from two Phase 3 clinical trials evaluating setmelanotide for the treatment of pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesities.
Both studies met the primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful reductions in weight loss and insatiable hunger.
Specifically, 80% (n=8/10) of patients with POMC deficiency obesity achieved more than a 10% reduction in weight over ~one year (p<0.0001). Mean weight reduction from baseline was -25.4%. Mean reduction from baseline in most hunger rating was -27.8%.
45% (n=5/11) of patients with LEPR deficiency obesity achieved at least a 10% reduction in weight (p=0.0001). Mean weight loss from baseline was -12.5% and mean reduction from baseline in most hunger rating was -41.9%.
No new safety signals were observed.
Complete data will be submitted for presentation at a future medical conference and publication.
89% (n=17/19) of eligible patients have elected to participate in the extension study.
The company expects to complete its rolling U.S. marketing application next quarter and will request Priority Review status. An application in Europe will follow.
Setmelanotide activates a protein called melanocortin 4 receptor (MC4R) that plays a key role in controlling appetite.
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