Soleno Therapeutics Announces Positive Data Showing Continued Significant Improvements in Symptoms of PWS following One Year Treatment with DCCR

Statistically significant reduction in hyperphagia and all other PWS behavioral parameters in Study C602

Statistically significant improvements compared to natural history of PWS from the PATH for PWS Study

On track for data submission to the FDA in Q3 2021

REDWOOD CITY, Calif., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced top-line results from the Company’s ongoing open-label extension study, C602, evaluating investigational, once-daily DCCR (Diazoxide Choline) Extended-Release tablets for patients with Prader-Willi syndrome (PWS) and its comparison to data from the PATH for PWS natural history study.

A total of 115 subjects were enrolled into C602, the extension study in patients with PWS who completed DESTINY PWS, an international, multi-center, randomized, double-blind, placebo-controlled study of DCCR in 127 PWS patients at 29 sites in the U.S. and UK. There are 95 subjects continuing to receive DCCR in C602. The PATH from PWS (PfPWS) study is an ongoing study sponsored by the Foundation for Prader-Willi Research (FPWR) to advance the understanding of the natural history in individuals with PWS. Data from subjects who received DCCR for 26 and 52 weeks were compared to results from matched subjects from the PfPWS. In all of these studies, changes in hyperphagia and PWS-related behaviors were assessed using the same questionnaires: the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), a caregiver completed 9-item validated questionnaire for assessing hyperphagia in PWS, and the Prader-Willi Syndrome Profile (PWS-P), which consists of caregiver responses to questions in six domains: aggressive behaviors, anxiety, compulsivity, depression, disordered thinking, and rigidity-irritability.  

Key Top-line Results of Study C602

Hyperphagia: The mean (SE) improvement in hyperphagia, the primary endpoint in the DESTINY PWS study, represented by a decrease in the HQ-CT total score, of -9.9 (0.77), was highly significant (p