Rhythm Pharma's Setmelanotide Shows Encouraging Action In Hypothalamic Obesity Study

  • Rhythm Pharmaceuticals Inc RYTM announced interim results from a Phase 2 trial of setmelanotide for severe obesity and hyperphagia.
  • As of the data cutoff date of May 6, 11 patients were evaluable for assessment, including nine patients who completed 16 weeks of treatment and two patients who discontinued early due to treatment-related adverse events. 
  • Data highlights from an interim analysis (N=11) include:
    • -17.2% mean percentage change in BMI.
    • -15.8% mean change in body weight from a baseline of 107.1 kg.
    • -15.9 kg mean weight loss from baseline.
  • Data highlights from an interim analysis of completers (n=9) include:
    • -19.5% mean change in BMI.
    • -17.8% mean change in body weight from a baseline of 107.8 kg.
    • -17.8 kg mean weight loss from baseline.
  • Setmelanotide also achieved a meaningful reduction in hunger scores. The mean change in hunger score was -2.7 on a scale of 1-10, with 10 being the most hungry.
  • Setmelanotide was observed to be generally well tolerated. 
  • Recently, the FDA approved a supplemental marketing application for Imcivree (setmelanotide) for Bardet-Biedl syndrome.
  • Price Action: RYTM shares are down 0.85% at $4.65 during the premarket session on the last check Tuesday.
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