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Soleno Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2020 Financial Results
REDWOOD CITY, Calif., March 03, 2021 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company
About this update from Soleno Therapeutics, Inc.
[{"type":"text","content":"REDWOOD CITY, Calif., March 03, 2021 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update and announced financial results for the fourth quarter and year ended December 31, 2020. Fourth Quarter 2020 and Recent Corporate Highlights Announced analysis of Phase 3 DESTINY PWS (C601) study evaluating once-daily Diazoxide Choline Controlled-Release (DCCR) tablets for patients with Prader Willi Syndrome (PWS), limited to data collected through March 1, 2020, before the onset of the COVID-19 pandemic Primary endpoint demonstrated a statistically significant change from baseline in hyperphagia Change was measured by the total score of a Hyperphagia Questionnaire for Clinical Trials (HQ-CT, 0-36): p=0.037 Statistically significant improvements were noted in all key secondary endpoints Clinical Global Impression of Improvement (CGI-I) at Visit 7: p=0.015Change from Baseline in Body Fat Mass (DXA) at Visit 7: p=0.004Caregiver Global Impression of Change (Caregiver GI-C) at Visit 7: p=0.031 The safety profile of DCCR remains generally consistent with the known profile of diazoxide and prior experience with DCCR, with no serious unexpected adverse events related to DCCR reportedSoleno continues its interactions with the FDA around this as well as other analyses of completed and ongoing studies of DCCR Hosted key opinion leader (KOL) webinar to discuss the treatment landscape and unmet need in PWS, impact of the COVID-19 pandemic on PWS patients and families, and an analysis of Phase 3 DESTINY PWS evaluating data generated prior to disruptions caused by the COVID-19 pandemicAnnounced collaboration agreement with Vanderbilt University to discover and develop novel ATP-dependent potassium (KATP) channel activators with the potential to treat rare diseases “We remain focused on our goal of advancing our late-stage DCCR program in PWS,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “Based on the substantial impact of the COVID-19 pandemic on PWS patients and families, we conducted further analysis of our Phase 3 DESTINY PWS study that evaluated data collected prior to the onset of the pandemic, which we highlighted at a recent KOL webinar. We observed statis...