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Rhythm Pharmaceuticals Presents New Data from Long-term Extension Trial Evaluating Setmelanotide in Bardet-Biedl Syndrome or POMC or LEPR Deficiency Obesity at ENDO 2022
-- Sustained weight loss observed following 18 to 36 months on therapy -- -- Setmelanotide shown to be well-tolerated for up to three years of treatment ----
About this update from Rhythm Pharmaceuticals, Inc.
[{"type":"text","content":"-- Sustained weight loss observed following 18 to 36 months on therapy -- -- Setmelanotide shown to be well-tolerated for up to three years of treatment ---- Data support continued efficacy and long-term use of setmelanotide in patients with BBS or POMC or LEPR deficiency obesity -- BOSTON, June 13, 2022 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company committed to transforming the care of people living with rare genetic diseases of obesity, today 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 Bardet-Biedl syndrome (BBS) or 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. “These presentations build on our strong pivotal trial data and further illustrate setmelanotide’s ability to safely deliver sustained, clinically meaningful weight loss for individuals living with severe obesity caused by BBS, or by POMC or LEPR deficiency,” said David Meeker, M.D., Chair, President and Chief Executive Officer of Rhythm. “Responses to our precision therapy are shown to be durable, with both adult and pediatric patients experiencing continued reductions in body weight-related measures throughout the long-term extension. This supports our belief in setmelanotide as a chronic therapy across our approved or registration-stage indications. As we approach the June 16 PDUFA goal date for BBS, we are eager to deliver setmelanotide to the waiting community, and we look forward to offering patients and their families a safe, effective medicine that can provide lasting benefit.” Bardet-Biedl SyndromeA total of 42 patients with BBS who were treated with setmelanotide in Rhythm’s Phase 2 or Phase 3 trial continued into the LTE. As of the data cutoff, 30 and 19 of these patients had received at least 18 and 24 months of setmelanotide therapy, respectively. The data were presented in a poster, “Long-term Efficacy of Setmelanotide in Patients with Bardet-Biedl Syndrome,” by Jesús Argente, M.D., Ph.D., Universidad Autónoma de Madrid in Spain. Highlights include: Mean...