Rhythm Pharmaceuticals, Inc. Presents Data on Mc4r Agonists Setmelanotide and Bivamelagon At Endo 2025

Published: 2025-07-13 04:05:21 ET RYTM

Published on 07/13/2025 at 04:05

Rhythm Pharmaceuticals, Inc. announced data from three new presentations on the Company's clinical programs for acquired hypothalamic obesity at the Endocrine Society's Annual Meeting (ENDO 2025) taking place July 12-15 in San Francisco, CA. Presentations on Rhythm's acquired hypothalamic obesity programs at ENDO 2025 include: Efficacy and Safety of Once-Daily Oral Bivamelagon in Acquired Hypothalamic obesity: Results from a Double-blind, Multicenter, Placebo-Controlled, Randomized Phase 2 Trial In a poster presentation, Vidhu Thaker, M.D., Pediatric Endocrinology, Columbia University, New York City, presented data from the Phase 2 SIGNAL trial evaluating bivamelagon, a daily oral, highly selective MC4R agonist, in patients with acquired hypothalamic obesity. Efficacy and Safety of Setmelanotide in Acquired Hypothalamic Obesity: Results from a Double-Blind, Multicenter, Place Bo-Controlled, Randomized phase 3 Trial In a live oral presentation, Susan Phillips, M.D., Ped pediatric Endocrinology, University of California San Diego/Rady Children's Hospital, San Diego, presented data from Rhythm's pivotal Phase 3 TRANSCEND trial evaluating setmelanotide, the largest randomized, placebo-controlled trial in acquired hypothalamic obesity to date.

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) to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. Rhythm estimates there are 5,000 to 10,000 people living with hypothalamic obesity in the U.S., 5,000 to 8,000 people living with hypothal ceramic obesity in Japan, and 3,500 to 10,000 people living With hypothalamic obesity in the E.U. Setmelanotide Indication: In the United States, setmelanotide is indicated to reduce excess body weight and maintaining weight reduction long term in adult & pediatric patients aged 2 years and older with syndromic and monogenic obesity due to BardET-Biedl syndrome (BBS) or Pro-opielanocortin (POMC), proprotein convertases subtilisin/kex in type 1 (PCSK1), or leptin receptor (LEPR).

In the United States, set Melanotide is indicated to reduce additional body weight and maintain weight reduction Long term in adult and pediatric patients aged 2 years and years and older with syndromIC or monogenic obesity due toardet-Biedl syndrome ("BBS") or Pro-opiomel anocortin (POMc), proprotein convertase subtILisin/kexin type1 (PCSK1), or insulin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC,PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).