Rhythm Pharma setmelanotide meets endpoints; on track for NDA filing
US biotech firm Rhythm Pharmaceuticals (Nasdaq: RYTM) saw its shares leap 19% to $22.63 yesterday, after the company announced positive top-line results from two pivotal, Phase III clinical trials evaluating setmelanotide, the company’s melanocortin-4 receptor (MC4R) agonist, for the treatment of pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesities.
Both studies met their primary endpoints and all key secondary endpoints, demonstrating a statistically significant and clinically meaningful effect on weight loss and reductions in insatiable hunger, or hyperphagia, in patients with POMC and LEPR deficiency obesities.
“We believe these statistically significant data demonstrate setmelanotide’s ability to induce marked weight loss and substantially reduce hunger and we are excited about the potential difference we can make in the lives of people with rare genetic disorders of obesity,” said Dr Keith Gottesdiener, chief executive of Rhythm.
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