Rhythm Pharmaceuticals (NASDAQ:RYTM) presented data that showed meaningful weight loss was sustained and progressed in patients with hypothalamic obesity treated with its setmelanotide for six months as part of the long-term extension of its Phase 2 trial.
Highlighted data included a:
- 21% mean reduction in BMI (body mass index) at month six from baseline, which progressed from 16.8% mean reduction in BMI at week 16 across 13 patients;
- 10 of 13 (76.9%) patients achieved 10% BMI reduction or greater at month six and all 13 patients achieved 5% BMI reduction or greater;
- 9.2 kg (23.9%) and 3.0 kg (6.3%) mean decreases observed in fat mass and lean muscle mass, respectively, at week 16 in pediatric patients;
- and a 1.7 point mean decrease from baseline in BMI-Z score from baseline in patients younger than 18.
The results to date have been “remarkable with setmelanotide demonstrating sustained and deepening reductions in multiple BMI measures at six months of treatment, showing progressive and consistent improvement over previously reported 16-week BMI reduction data,” Christian Roth, M.D., Seattle Children’s Research Institute and Division of Endocrinology, Department of Pediatrics, University of Washington, said in a statement.
“This impressive response adds to the evidence suggesting setmelanotide may provide a meaningful clinical benefit for patients with this disease who currently have no approved therapeutic options,” he added.
Dr. Roth presented these data during The Endocrine Society Annual Meeting and Expo (ENDO 2023) in Chicago.
