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<0.001 for both comparisons).

PWS-related behaviors: As with hyperphagia, highly statistically significant and clinically meaningful improvements were seen in DCCR treated participants compared to those in the PATH study in all behavioral domains of the PWSP at 6 and 12 months (p≤0.003 for all domains).

"The PATH for PWS study is an important evaluation of the natural history of individuals with PWS," said Dr. Theresa Strong, Director of Research Programs for FPWR. "These highly significant improvements with long-term DCCR treatment compared to the PATH data suggest that DCCR has the potential to provide much needed and substantial improvement in the lives of those living with PWS and their families. We are excited to see DCCR advance through the regulatory process and look forward to continuing to support Soleno in its efforts."

"DCCR has the potential to substantially improve the quality of life for individuals with PWS and their families," said PATH Study Principal Investigators, Jennifer Miller, M.D. and Shawn McCandless, M.D. "These data clearly demonstrate that long-term treatment with DCCR resulted in changes in hyperphagia and other behavioral complications of PWS that are meaningfully improved compared to the natural history of the disease. We believe these results support the significant potential of DCCR in PWS and are eager to offer a much-needed treatment option to patients in need, if approved."