New data from long-term extension trial evaluating setmelanotide in POMC or LEPR deficiency obesity at ENDO 2022.
Rhythm Pharmaceuticals, Inc.announced new data from the Company’s long-term extension (LTE) trial, which show continued body mass index (BMI) and weight reductions in patients with POMC or LEPR deficiency obesity (biallelic) receiving between 18 months and three years of setmelanotide therapy.
Rhythm and its collaborators delivered these data in poster presentations at the Endocrine Society Annual Meeting & Expo (ENDO), being held June 11-14, 2022 in Atlanta.
POMC or LEPR deficiency obesity (biallelic): A total of 24 patients with POMC or LEPR deficiency obesity who were treated with setmelanotide in Rhythm’s Phase II or Phase III trial continued into the LTE. As of the data cutoff, 21 and 15 of these patients had received at least 24 or 36 months of setmelanotide therapy, respectively. These data were presented in a poster entitled, “Long-term Efficacy of Setmelanotide in Patients With POMC or LEPR Deficiency Obesity,” by Karine Clément, M.D., Ph.D., Professor of Nutrition at Pitié-Salpêtrière Hospital, Sorbonne Université and Head of the INSERM Nutriomics Laboratory in Paris.
Highlights include: i. Across all patients, mean (SD) percent change in BMI was -16.7% (16.0%; n=21) and -17.5% (20.5%; n=15) after 24 and 36 months of treatment, respectively. ii. Patients 18 years old or older achieved a mean (SD) percent change in body weight of -16.7% (16.2%; n=10) and -13.5% (15.9%; n=8) after 24 and 36 months of treatment, respectively. iii. Seven of 10 patients (70%) and five of eight patients (62.5%) achieved greater than 10% weight reduction after 24 and 36 months of treatment, respectively. iv. Patients younger than 18 years old achieved a mean (SD) change in BMI Z score of -0.94 (0.95; n=10) and -0.73 (1.41; n=4) after 24 and 36 months, respectively. v. Eight of 10 patients (80%) and two of four patients (50%) younger than 18 years old achieved BMI Z score reductions of greater than 0.3 points at 24 and 36 months of treatment, respectively. vi. As of the data cutoff, a total of 24 patients were receiving ongoing treatment in the LTE trial; three patients discontinued treatment, none due to adverse events.
Consistent with prior clinical observations, setmelanotide was generally well tolerated in the LTE trial across both indications and no new safety signals were observed.
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