Statistically Significant Improvements with DCCR Compared to Natural History of PWS from the PATH for PWS Study in Hyperphagia and PWS-related Behaviors
REDWOOD CITY, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced the publication of the comparison of results from the Company’s Phase 3 placebo-controlled study (C601) and open-label extension study (C602) evaluating investigational, once-daily DCCR (Diazoxide Choline) Extended-Release tablets in patients with Prader-Willi syndrome (PWS), to data from the PATH for PWS (PATH) natural history study, in the Journal of Neurodevelopmental Disorders. The article, entitled, “Behavioral Changes in Patients with Prader-Willi Syndrome Receiving Diazoxide Choline Extended-Release Tablets Compared to the PATH for PWS Natural History Study,” can be found HERE.
Data from DCCR-treated participants in the C602/C602 cohort were compared to results from a cohort of comparable participants from PATH using the same caregiver-completed questionnaires to measure hyperphagia (Hyperphagia Questionnaire for Clinical Trials [HQ-CT]) and PWS-related behaviors (the Prader-Willi Syndrome Profile [PWSP]) in six domains: aggressive behaviors, anxiety, compulsivity, depression, disordered thinking, and rigidity-irritability.
Hyperphagia: Participants treated with DCCR showed highly statistically significant and clinically meaningful improvement with DCCR administration relative to participants in the PATH study at 6 and 12 months (p