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Soleno Therapeutics Announces Peer-Reviewed Publication of Results from Previously Completed Phase 3 Trial of DCCR for Treatment of Prader-Willi Syndrome
REDWOOD CITY, Calif., Jan. 26, 2023 (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., Jan. 26, 2023 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that results from the Company’s previously completed Phase 3 DESTINY PWS (C601) trial of DCCR (Diazoxide Choline) Extended-Release tablets for the treatment of Prader-Willi Syndrome (PWS) have been published in a peer-reviewed journal. The article, entitled, “Diazoxide Choline Extended-Release Tablet in People with Prader-Willi Syndrome: A Double-Blind Placebo-Controlled Trial,” was published in The Journal of Clinical Endocrinology and Metabolism (JCEM) and can be found here. “We are pleased that the data from the C601 study of DCCR in PWS have been published in a prestigious peer-reviewed journal, JCEM,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “Based on the promising results from the trial, as well as discussions with the U.S. Food and Drug Administration, we initiated a randomized withdrawal period of the open-label Phase 3 extension study C602, which has the potential to support the submission of a New Drug Application. Trial subjects are currently being randomized at our clinical sites.” About PWSThe Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births in the U.S. The hallmark symptom of this disorder is hyperphagia, a chronic feeling of insatiable hunger that severely diminishes the quality of life for PWS patients and their families. Additional characteristics of PWS include behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development. Hyperphagia can lead to significant morbidities (e.g., obesity, diabetes, cardiovascular disease) and mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior). In a global survey conducted by the Foundation for Prader-Willi Research, 96.5% of respondents (parent and caregivers) rated hyperphagia and 92.9 % body composition as the most important or a very important symptom to be relieved by a new medicine. There are currently no approved therapies to treat the hyperphagia/appetite, metabolic, cognitive f...