Business
Rhythm Pharmaceuticals Announces Positive Results from Phase 2 Study of Once-weekly Formulation of Setmelanotide in Healthy Obese Volunteers
-- Once-weekly formulation of setmelanotide achieved weight loss efficacy comparable to daily-dosing formulation – -- Both weekly and daily formulations of
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- Once-weekly formulation of setmelanotide achieved weight loss efficacy comparable to daily-dosing formulation –\n -- Both weekly and daily formulations of setmelanotide were observed to be safe and well-tolerated – -- Pharmacokinetics analysis showed weekly formulation of setmelanotide trough drug concentration similar to daily formulation – BOSTON, June 24, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity, today announced interim data from a Phase 2 study evaluating a once-weekly formulation of setmelanotide, the Company’s investigational melanocortin-4 receptor (MC4R) agonist. Healthy obese people treated with the weekly formulation of setmelanotide achieved comparable weight loss to those treated with the daily formulation, and both weekly and daily formulations of setmelanotide were observed to be safe and well-tolerated. Pharmacokinetics (PK) analyses showed similar trough drug concentrations for the daily and weekly formulations over the duration of therapy. “As a daily injection, setmelanotide has achieved statistically significant and clinically meaningful weight loss in patients with rare genetic disorders of obesity across multiple Phase 2 and Phase 3 clinical trials,” said Murray Stewart, M.D., Chief Medical Officer of Rhythm. “These new data suggest that weekly setmelanotide may provide the same clinical benefit in a more convenient formulation, with the potential to reduce the burden on patients without compromising safety or efficacy. We look forward to evaluating these data further and continuing discussions with the U.S. Food and Drug Administration (FDA) about our path to registering weekly setmelanotide.” The Phase 2 study was designed to assess pharmacokinetics and the safety and tolerability of the weekly formulation of setmelanotide and its effect on reducing body weight in healthy individuals with a body mass index (BMI) of 40 kg/m2 or greater. A total of 75 individuals were included in this interim analysis: 42 individuals were treated with weekly setmelanotide (10mg, 20mg, or 30mg doses) for 12 weeks, 23 individuals were treated with placebo for 12 weeks, and ten individuals were treated with daily setmelanotide (2mg daily for one week, foll...