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Benzinga
Benzinga
Technology
Vandana Singh

Rhythm Pharma Shares Fall After Modifications To Setmelanotide Trials In Rare Diseases of Obesity

Rhythm Pharmaceuticals Inc (NASDAQ:RYTMwill modify its Phase 3 EMANATE and ongoing Phase 2 DAYBREAK trials of setmelanotide in rare genetic diseases of obesity

  • Recent FDA feedback indicated that additional clinical trials to support potential registration for non-rare patient populations would likely be required. 
  • Hence, Rhythm eliminated a fifth sub-study intended to evaluate setmelanotide in patients with a PCSK1 N221D variant. 
  • The EMANATE trial now includes four independent sub-studies evaluating setmelanotide in obesity due to a heterozygous variant of the POMC/PCSK1 genes, LEPR gene, SRC1 gene, and the SH2B1 gene. 
  • Rhythm estimates that patients with rare variants in these genes represent a potential addressable U.S. population of approximately 53,000.
  • The first patient in EMANATE trial has been enrolled.
  • Rhythm anticipates 12-18 months to enroll approximately 400 patients in the EMANATE trial.
  • Related: Why Rhythm Pharmaceuticals Shares Are Falling Today?
  • In the Phase 2 DAYBREAK trial, Rhythm modified enrollment criteria to focus initially on rare variants associated with 10 prioritized MC4R-relevant genes. 
  • The Company decided to pause the enrollment of patients with variants in additional MC4R pathway genes.
  • Rhythm began enrolling DAYBREAK in January 2022. The trial will now enroll approximately 100 to 200 patients.
  • Price Action: RYTM shares are up 16.8% at $9.75 during the market session on the last check Wednesday.
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