Rhythm Pharma Initiates Phase 1 Study with First Dose of Weekly MC4R Agonist RM-718

Rhythm Pharmaceuticals, a biopharmaceutical firm specializing in rare neuroendocrine disorders, has commenced dosing for its Phase 1 clinical trial of RM-718. This experimental medication, an MC4R-specific agonist, is developed to be administered weekly and is designed to prevent hyperpigmentation while sparing the MC1R receptor.
David Meeker, CEO of Rhythm, expressed optimism about RM-718's potential to alleviate hyperphagia and severe obesity, common symptoms of MC4R-related diseases. The drug is anticipated to offer a weekly dosing option without causing skin darkening.
The trial is divided into three stages: single ascending doses for healthy obese participants aged 18-55 (Part A), multiple ascending doses for the same demographic (Part B), and multiple ascending doses for patients with hypothalamic obesity aged 12-65 (Part C). The study employs a double-blind, placebo-controlled, randomized approach for the initial two parts, with 96 participants expected to enroll.
RM-718 has shown promise in preclinical trials, indicating its potential to reduce body weight and hunger. Rhythm Pharmaceuticals, headquartered in Boston, is dedicated to improving the lives of those with rare neuroendocrine conditions. The company's flagship product, IMCIVREE (setmelanotide), is an FDA-approved MC4R agonist for chronic weight management in patients with specific genetic deficiencies or Bardet-Biedl syndrome.
Setmelanotide's use is restricted to patients with genetic obesity conditions and is not suitable for general obesity types. Serious hypersensitivity to the drug is a contraindication. Precautions include monitoring for skin pigmentation changes, heart rate and blood pressure, sexual arousal disturbances, depression, suicidal ideation, and hypersensitivity reactions. The drug is not recommended for neonates or infants due to the risk of benzyl alcohol-related adverse reactions.
Common adverse effects of setmelanotide are skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erections.

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