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Rhythm Pharmaceuticals Announces First Patients Dosed in Phase 2 Trial Evaluating Oral MC4R Agonist LB54640 in Hypothalamic Obesity
-- LB54640 has shown targeted effect on MC4R without hyperpigmentation -- BOSTON, July 23, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq:
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- LB54640 has shown targeted effect on MC4R without hyperpigmentation -- BOSTON, July 23, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, today announced that the first patients have been dosed in the Company’s Phase 2 clinical trial evaluating LB54640, an investigational oral melanocortin-4 receptor (MC4R) agonist, in hypothalamic obesity. “Based on LG Chem’s significant preclinical work and encouraging results from a Phase 1 trial, we believe LB54640 has the potential to be an effective oral therapy for treating MC4R pathway diseases without hyperpigmentation,” said David Meeker, M.D., Chair, Chief Executive Officer and President of Rhythm Pharmaceuticals. “We look forward to advancing this molecule with the goal of offering a full portfolio of treatment options to patients struggling with hyperphagia and severe obesity and ensuring they get the treatment that is right for them.” The Phase 2 trial is a randomized, placebo-controlled, double-blind study to assess the effect of LB54640 on safety, weight reduction, hunger, and quality of life in patients 12 years of age and older (N=28) with hypothalamic obesity. Patients will take an oral daily dose of either LB54640 (low, middle, or high dose) or placebo for 14 weeks. The primary endpoint of the study is the change from baseline in body mass index after 14 weeks of treatment, and patients may continue on therapy for up to 52 weeks. Rhythm entered into a global licensing agreement with LG Chem, Ltd. (\"LG Chem\") for LB54640 in January 2024. In a Phase 1 trial in healthy overweight adults, LB54640 demonstrated dose-dependent weight reduction and a favorable safety profile with no changes in blood pressure or heart rate observed and no hyperpigmentation observed. About Rhythm Pharmaceuticals Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE® (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the U.S. Food and Drug Administration (FDA) for chronic weight management in adult and pediatric patients 6 years of age and older ...