Camurus announces that the company's licse partner Rhyhythm 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. 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. The weekly formulation of the MC-4R agonist setmelanotide (CAM4072) is developed by Camurus' partner Rhythm Pharmaceuticals for the treatment of a range of rare genetic disorders of obesity.

The product candidate is based on Camurus' proprietary FluidCrystal[®] injection depot technology and intended for weekly self-administration and is designed to improve treatment compliance and adherence. CAM4072 has been successfully studied in one Phase 1 trial and one Phase 2 trial including study participants with severe obesity. The positive Phase 2 results demonstrated that the subjects treated with the weekly formulation achieved comparable weight loss to those treated with the daily formulation.

Furthermore, weekly setmelanotide was observed to be well-tolerated with a safety profile similar to the daily formulation. Rhythms' short-acting formulation of setmelanotide, IMCIVREET, was approved by the FDA in November 2020 for the treatment of rare obesity disorders related to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. This was followed by approval in the EU in July 2021.