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.tiberg@camurus.com

Fredrik Joabsson, Chief Business Development Officer
Tel. +46 (0)70 776 17 37
ir@camurus.com

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.

About Camurus
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.

References
1. https://ir.rhythmtx.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-positive-results-phase-2-study

This information was submitted for publication at 4.30pm CET on 13 January 2022.

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