Camurus announces dosing initiated in Phase 3 trial of weekly setmelanotide in patients with genetic obesity disorder

Camurus (NASDAQ STO: CAMX) today announces that the company’s license partner Rhythm Pharmaceuticals has dosed the first patients in a Phase 3 trial evaluating weekly setmelanotide subcutaneous depot in patients six years of age and older with a rare genetic disease of obesity.

“We are pleased with the progress of our collaboration with Rhythm and today’s announcement of the first dosing in a randomized controlled Phase 3 trial of our long-acting formulation of setmelanotide in patients with rare genetic obesity disorders.” says Dr. Fredrik Tiberg, CEO and Head of R&D at Camurus. “The weekly formulation is based on Camurus’ proprietary FluidCrystal injection depot technology and is designed to offer patients a more convenient dosing regimen and potential for improved treatment adherence.”

The Phase 3 trial is a randomized, double-blind switch trial in patients with obesity due to biallelic or heterozygous proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) genetic variants or a clinical diagnosis of Bardet-Biedl Syndrome (BBS) with genetic confirmation, who were previously enrolled in Rhythm’s long-term, open-label daily setmelanotide extension trial. The trial is expected to enroll 30 patients, randomized 1:1 to receive either once weekly setmelanotide and once daily placebo, or once daily setmelanotide and once weekly placebo for 13 weeks. Following the 13-week randomized treatment period, the trial will crossover to an open-label, 13-week study in which all patients will receive once-weekly setmelanotide. The primary efficacy endpoint is proportion of patients with no weight gain.