Soleno Therapeutics Provides Recap of Key Opinion Leader Webinar on DCCR for Treatment of Prader-Willi Syndrome

Recent analysis of Phase 3 DESTINY PWS limited to data collected before the onset of the COVID-19 pandemic shows statistical significance in the primary and key secondary endpoints

REDWOOD CITY, Calif., Feb. 05, 2021 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today hosted a Key Opinion Leader (KOL) webinar and provided an update on the Company’s ongoing Phase 3 program evaluating once-daily Diazoxide Choline Controlled Release (DCCR) tablets for the treatment of Prader-Willi Syndrome (PWS).

“PWS is estimated to impact about 10,000 – 20,000 people in the U.S., and is characterized by hyperphagia, an insatiable feeling of hunger, and various other behavioral and metabolic abnormalities that severely impact the daily lives of patients and their families,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “Given the considerable impact of the COVID-19 pandemic, particularly for individuals with PWS and their families as highlighted during our webinar, it was critical for us to evaluate the data from our Phase 3 DCCR trial that was generated prior to the significant disruptions caused by the pandemic.”

“Our analysis of the data through March 1, 2020 found statistically significant differences between DCCR and placebo patients for the primary and all key secondary endpoints. We continue to be encouraged by these data and positive changes experienced by our subjects with DCCR treatment. We look forward to continuing our interactions with the regulatory authorities,” concluded Dr. Bhatnagar.

In an analysis of study results with data through March 1, 2020, a date shortly before a national emergency was declared due to COVID-19, the primary endpoint demonstrated a statistically significant change from baseline in hyperphagia for DCCR compared to placebo. The change was measured by the total score of a Hyperphagia Questionnaire for Clinical Trials (HQ-CT, 0-36). An improvement in HQ-CT is represented by a decrease in the score. Key secondary endpoints, as well as several additional subjective endpoints measuring improvement in behavior and communication, that were not significant in the top-line analyses, were also all significant in the analysis of data through March 1, 2020. No significant differences in safety were noted compared to the top-line analysis.