Rhythm Pharma’s obesity drug shows positive results in two Phase 3 trials

pharmafile | August 8, 2019 | News story | Research and Development Rhythm pharma, clinical trial, health, obesity, pharma 

Rhythm Pharma’s obesity drug setmelanotide achieved positive results in two pivotal Phase 3 trials.

In both studies, setmelanotide met its primary endpoints and all key secondary endpoints demonstrating a clinically meaningful and statistically significant effect on weight loss and reductions in insatiable hunger in patients with pro-opiomelanocortin (POMC) and leptin receptor (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 Officer of Rhythm.

“We believe these pivotal data are the first step towards making a positive impact for people affected by rare genetic disorders of obesity who have grown up with insatiable hunger and early-onset, rapid weight gain that often leads to debilitating comorbidities. We believe this milestone moves us closer to delivering a treatment for numerous MC4R pathway-driven disorders of obesity. We are working to advance setmelanotide to its first regulatory submission in POMC and LEPR deficiency obesities.”

While eight of 10 patients in the POMC deficiency obesity group achieved the primary endpoint of 10% weight loss over a year, five of 11 of those in the LEPR group achieved the primary endpoint of greater than 10 weight loss over a year.

Setmelanotide demonstrated a clinically meaningful impact on severe hunger and obesity with 17 of 19 eligible patients choosing to participate in the extension study to continue setmelanotide treatment,” said Dr Murray Stewart, Chief Medical Officer of Rhythm Pharmaceuticals.

“Importantly, during withdrawal periods in both studies, patients experienced statistically significant, consistent increases in weight and hunger. Following re-initiation of therapy, the majority of patients resumed weight loss and hunger response. We believe these data speak to setmelanotide’s potential to help restore the function of the MC4R pathway in regulating weight and appetite control.”

Louis Goss

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