Camurus announces dosing initiated in Phase 3 trial of weekly setmelanotide in patients with genetic obesity disorder
Lund, Sweden — 13 January 2022 — 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.
For more information
Fredrik Tiberg, President & CEO
Tel. +46 (0)46 286 46 92
Fredrik Joabsson, Chief Business Development Officer
Tel. +46 (0)70 776 17 37
About weekly setmelanotide
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.1 Furthermore, weekly setmelanotide was observed to be well-tolerated with a safety profile similar to the daily formulation.
Rhythms’ short-acting formulation of setmelanotide, IMCIVREE™, 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.
Camurus is a Swedish science-led biopharmaceutical company committed to developing and commercializing innovative and differentiated medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal® drug delivery technologies and its extensive R&D expertise. Camurus’ clinical pipeline includes products for the treatment of cancer, endocrine diseases, pain and addiction, which are developed in-house and in collaboration with international pharmaceutical companies. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com.
This information was submitted for publication at 4.30pm CET on 13 January 2022.