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Soleno Therapeutics Announces Peer-Reviewed Publication of Results from Long-Term Open-Label Study of DCCR in Prader-Willi Syndrome
One-Year Administration of DCCR in PWS Patients from DESTINY-PWS Demonstrates Significant Improvements in Hyperphagia and Other Behavioral Complications
About this update from Soleno Therapeutics, Inc.
[{"type":"text","content":"One-Year Administration of DCCR in PWS Patients from DESTINY-PWS Demonstrates Significant Improvements in Hyperphagia and Other Behavioral Complications\nREDWOOD CITY, Calif., Nov. 06, 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 publication of one-year results from the Phase 3 DESTINY PWS study and the open-label extension period of Study C602 evaluating investigational, once-daily DCCR (Diazoxide Choline) Extended-Release tablets for patients with Prader-Willi syndrome (PWS). The paper, entitled “Diazoxide Choline Extended-Release Tablet in People with Prader-Willi Syndrome: Results from Long-Term Open-Label Study,” was published in the peer-reviewed journal Obesity and can be found online here. “We are pleased to publish results from the long-term study of DCCR demonstrating significant, sustained reductions in hyperphagia,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “Together with positive results from our recently completed randomized withdrawal period of Study C602, DCCR has shown significant and clinically meaningful benefits for the most burdensome symptoms of PWS. We believe it has the potential to be a safe and effective therapy for patients with PWS. We anticipate submitting an NDA to the FDA for DCCR in mid-2024.” The publication features results from 52-week administration of DCCR in participants with PWS enrolled in DESTINY PWS and/or Study C602, the long-term open-label extension study of participants who completed DESTINY PWS. The primary efficacy endpoint was change in hyperphagia total score from baseline, as measured using the Hyperphagia Questionnaire for Clinical Trials (HQ-CT). Other endpoints included behavioral assessments using the PWS Profile Questionnaire (PWSP), body composition, hormonal and metabolic measures, disease severity and safety. Key Highlights from the Publication: Primary Endpoint: Hyperphagia Statistically significant, clinically meaningful decreases in HQ-CT total score (mean [SE]) from baseline in overall population after receiving DCCR for 52 weeks (-9.9 [0.77]; p","length":2721,"tagName":"div"}]