Rhythm Pharmaceuticals Announces Nature Medicine Publication of Longer-Term Data from Phase 2 Study of Setmelanotide for Treatment of LEPR Deficiency Obesity
Longer-term data from open label study show reductions in hyperphagia and body weight
In vitro analyses advance understanding of setmelanotide’s activity at the MC4 receptor, a part of a key pathway regulating energy homeostasis and appetite
The longer-term data from Rhythm’s open label study show that once daily subcutaneous injection of setmelanotide resulted in reductions in hyperphagia and body-weight in three patients with LEPR deficiency obesity. The safety and tolerability of setmelanotide were consistent with previous findings and no serious adverse events were reported. Researchers also conducted a series of in vitro analyses of MC4R function with data suggesting that:
- setmelanotide’s mechanism for MC4R activation may differentiate from the natural ligand and first-generation compounds;
- setmelanotide might overcome the presence of the naturally occurring neurotransmitter that inhibits the activation of MC4R; and,
- setmelanotide may rescue specific MC4R mutations where the natural ligand cannot.
Rhythm is currently enrolling patients in its pivotal Phase 3 clinical trial evaluating setmelanotide in LEPR deficiency obesity. Clinical trial sites are open across
“We are pleased to recognize the publication of longer-term Phase 2 study results in the peer-reviewed journal Nature Medicine, which represents an important milestone for our clinical development program and for people living with rare genetic disorders of obesity who currently do not have approved treatment options,” said
Rhythm is a biopharmaceutical company focused on the development and commercialization of therapies for the treatment of rare genetic disorders of obesity. Rhythm is currently evaluating the efficacy and safety of setmelanotide, the Company’s first-in-class melanocortin-4 receptor (MC4R) agonist, in Phase 3 studies in patients with pro-opiomelanocortin (POMC) deficiency obesity (which includes deficiencies in both the POMC and PCSK1 genes) and leptin receptor (LEPR) deficiency obesity. Rhythm also supports
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