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SOLENO THERAPEUTICS Soleno Therapeutics Provides Recap of Key Opinion Leader Webinar on DCCR for Treatment of Prader - Willi Syndrome February 5 , 2021 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 . Analysis of Primary Endpoint Change from Baseline in Hyperphagia LS Mean Difference [ DCCR - Placebo ] p - value Key Secondary Endpoints Top - line analysis June 2020 DCCR ( N = 82 ) -5.94 ( 0.88 ) Placebo ( N = 42 ) -4.27 ( 1.15 ) Data through March 1 , 2020 DCCR ( N = 80 ) -6.64 ( 1.00 ) Placebo ( N = 41 ) -3.51 ( 1.28 ) -1.67 0.198 -3.13 0.037 Clinical Global Impression of Improvement ( CGI - I ) at Visit 7 Top - line analysis June 2020 Data through March 1 , 2020 p - value p - value 0.03 0.015 0.03 0.004 Change from Baseline in Body Fat Mass ( DXA ) at Visit 7 Caregiver Global Impression of Change ( Caregiver GI - C ) at Visit 7 0.41 0.031 In addition to the pre - COVID - 19 data presented by Soleno at the webinar , Theresa Strong , Ph.D. , co - founder and Director of Research Programs at the Foundation for Prader - Willi Research , provided an overview of the impact of the COVID - 19 pandemic on more than 300 PWS patients and their families . Results from the Global PWS Registry's " Impact of COVID " Survey emphasized that PWS patients and their caregivers have experienced significant disruptions due to the COVID - 19 pandemic . A significant proportion of caregivers ( 85 % ) reported more stress . For patients , lack of social activity , remote learning and the loss of in - person therapy have had a substantial negative impact , with the loss of routine and structure contributing to increased challenges in food control and behavioral management . Jennifer Miller , M.D. , Director of the University of Florida Health Prader - Willi Syndrome Program and a Professor in the Division of Pediatric Endocrinology at the UF Department of Pediatrics , provided a summary of PWS and the obstacles faced by PWS patients and their families . Dr. Miller also reviewed the current treatment landscape and unmet need in PWS , as well as the positive biochemical , physical , and behavioral changes observed to date with DCCR treatment in her patients . A replay of the event is available in the Investors section on the Company's website at www.soleno.life . About Diazoxide Choline Controlled - Release ( DCCR ) Tablet Diazoxide Choline Controlled - Release tablet is a novel , proprietary extended - release , crystalline salt formulation of diazoxide , which is administered once - daily . The parent molecule , diazoxide , has been used for decades in thousands of patients in a few rare diseases in neonates , infants , children and adults , but has not been approved for use in PWS . Soleno conceived of and established extensive patent protection on the therapeutic use of