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Soleno Therapeutics Announces Top-line Results from Phase III Trial of DCCR for Treatment of Prader-Willi Syndrome
Study Did Not Meet Statistical Significance for Primary Endpoint, but Showed Significant Improvements in Prespecified Subgroup with Severe Hyperphagia
About this update from Soleno Therapeutics, Inc.
[{"type":"text","content":"Study Did Not Meet Statistical Significance for Primary Endpoint, but Showed Significant Improvements in Prespecified Subgroup with Severe Hyperphagia\n Significant Positive Changes Also Seen in Two of Three Key Secondary Endpoints Interim Analysis of Ongoing Extension Study (C602) Showed Further Reductions in Hyperphagia of 48% after Six Months of DCCR Treatment Soleno to Host Conference Call and Live Webcast Today at 5:00 PM ET/2:00 PM PT REDWOOD CITY, Calif., June 08, 2020 (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 Phase III trial, DESTINY PWS (C601), evaluating once-daily Diazoxide Choline Controlled Release (DCCR) tablets for patients with Prader-Willi Syndrome (PWS). DESTINY PWS/C601 The study did not meet its primary endpoint of change from baseline in hyperphagia. 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. The mean (SE) change from baseline for DCCR was -5.94 (0.879) and for placebo was -4.27 (1.145). The least squares mean difference in HQ-CT score of DCCR compared with placebo was -1.67 (1.294); 95% confidence interval (-4.24, 0.89); p=0.1983. Significant changes were observed in two of three key secondary endpoints from baseline to week 13 in subjects receiving DCCR as compared to placebo: Improvement in Clinical Global Impression of Improvement (CGI-I) score as assessed by the investigator (p=0.029)Reduction of body fat mass measured by DXA scan (p=0.025) In a prespecified subgroup of subjects (n=61) with more severe hyperphagia, as identified by a dichotomized median baseline HQ-CT score of >22, the mean (SE) change from baseline for DCCR (n=42) was -9.67 (1.429) and for placebo (n=19) was -4.26 (1.896). The least squares mean difference in HQ-CT score of DCCR compared with placebo was -5.41 (2.093); 95% confidence interval (-9.60, -1.22); p=0.0124. In addition to the reduction in total body fat mass, other body composition changes in DCCR compared to placebo included significant decreases in trunk fat mass (p = 0.047), and improvement in lean body mass to fat mass ratio (p=0.001). Fat mass changes...