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Soleno Therapeutics Announces Presentation of Body Composition Results from DESTINY PWS, a Phase III Trial of DCCR in Prader-Willi Syndrome
REDWOOD CITY, Calif., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company
About this update from Soleno Therapeutics, Inc.
[{"type":"text","content":"REDWOOD CITY, Calif., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced presentation of body composition data from the Company’s Phase III trial, DESTINY PWS (C601), evaluating once-daily Diazoxide Choline Controlled Release (DCCR) tablets for patients with Prader-Willi Syndrome (PWS). The results were presented today by Parisa Salehi, M.D., Clinical Director of the Prader-Willi Syndrome Clinic at Seattle Children’s Hospital, in a late-breaking oral presentation at The Obesity Society’s ObesityWeek® 2020 meeting. Dr. Salehi presented the data on behalf of the DESTINY PWS Investigators.\n DESTINY PWS is a randomized, double-blind, placebo-controlled Phase III study of once daily oral administration of DCCR in 127 PWS patients conducted at 29 sites in the U.S. and U.K. The objective of the study was to assess the efficacy and safety of DCCR in subjects with genetically-confirmed PWS aged four years and older and weighing between 20 and 134 kg. Patients who completed the double-blind study enrolled in study C602, an ongoing open-label, extension study. Updated top-line results were previously announced in September 2020 that demonstrated DCCR’s beneficial impact on hyperphagia, the predominant symptom of PWS, other behaviors and body composition abnormalities typical of PWS. Key results for effects on body composition and adipokines following DCCR treatment were presented at ObesityWeek 2020 as follows: Fat mass and body mass: Significant reductions in fat mass (p=0.0027) were observed after 13 weeks of double-blind treatment- Greater mean reductions in fat mass were observed in those participants weighing more than 100 kg at baseline (placebo-adjusted difference -4.82 kg)Linear exposure-response relationship for fat mass was significant with greater fat loss occurring at higher circulating drug concentrations (p","length":2403,"tagName":"div"}]