Business UpdateJun 15, 2026, 04:12 PM
Rhythm Pharmaceuticals Presents Positive Setmelanotide Data in PWS, HO, and BBS
AI Summary
Rhythm Pharmaceuticals announced new data presentations from its clinical trials at the Endocrine Society's Annual Meeting (ENDO 2026). Interim six-month data from a Phase 2 trial of setmelanotide in Prader-Willi syndrome (PWS) patients demonstrated clinically meaningful improvements in BMI, body composition, hyperphagia, and anxiety. The company also presented long-term efficacy and safety data for setmelanotide in acquired Hypothalamic Obesity (HO) and results for oral bivamelagon in HO, as well as real-world data in Bardet-Biedl Syndrome (BBS).
Key Highlights
- Rhythm Pharmaceuticals presented interim six-month data from its exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome (PWS).
- Treatment with setmelanotide showed a mean BMI reduction of -3.06% in 17 patients.
- Setmelanotide achieved preservation of lean mass (+0.74% mean gain) and reductions in fat mass (-4.19% mean loss) across 16 patients.
- Eight of 10 patients with moderate to severe hyperphagia achieved clinically meaningful improvement in hyperphagia scores.
- Rhythm also presented long-term efficacy data for setmelanotide in acquired Hypothalamic Obesity (HO) showing a -18.9% mean BMI reduction.
- Data on oral bivamelagon in acquired HO showed a mean BMI reduction of up to -16.6% after one year.
- Real-world data in Bardet-Biedl Syndrome (BBS) showed 62% of adults achieved >=10% body weight loss after 12 months.
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