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Soleno Therapeutics Announces Data Presentation Showing that Resumption of Treatment with VYKAT(TM) XR after a Randomized Withdrawal Period was Associated with Significant Improvements in Hyperphagia and Behavioral Symptoms in Participants with Prader...
Soleno Therapeutics Announces Data Presentation Showing that Resumption of Treatment with VYKAT(TM) XR after a Randomized Withdrawal Period was Associated
About this update from Soleno Therapeutics, Inc.
[{"type":"text","content":"Soleno Therapeutics Announces Data Presentation Showing that Resumption of Treatment with VYKAT(TM) XR after a Randomized Withdrawal Period was Associated with Significant Improvements in Hyperphagia and Behavioral Symptoms in Participants with Prader-Willi Syndrome \n REDWOOD CITY, Calif., May 20, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced data presented from its clinical development program of VYKAT™ XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, at the Pediatric Endocrine Society (PES) Annual Meeting 2025, which was held May 15-18 in National Harbor, Maryland, USA. The presentation showed that resumption of VYKAT XR treatment in participants with PWS following a 16-week randomized withdrawal was associated with significant improvements in both hyperphagia and behavioral symptoms. “We are pleased to share the results from our ongoing clinical development program for VYKAT XR,” said Anish Bhatnagar, M.D., Chairman and Chief Executive Officer of Soleno Therapeutics. “These results support the effectiveness of VYKAT XR in managing the critical symptoms of PWS and highlight the importance of long-term, continuous treatment.” Data Presented at the 2025 Pediatric Endocrine Society (PES) Annual Meeting Following long-term open label treatment with VYKAT XR for approximately 3 years (C602-OLE) and 16 weeks of randomized withdrawal (C602-RWP), participants who were randomized to placebo and restarted VYKAT XR in the open-label Study C614 showed improvements in hyperphagia by 13 weeks, with continued benefit through one year. Specifically, these participants showed a 6.3-point reduction in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) total score at one year —returning to levels similar to their pre-withdrawal baseline. Behavioral improvements were also demonstrated through one year, with improvements across all six domains assessed. About PWSThe Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The hallmark symptom of this disorder is hyperphagia, a chronic and life-threatening condition characterized by feelings of intense, persistent hunger, food pre-occupation, and an extreme drive to seek and consume food,...