Business
Soleno Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2019 Financial Results
REDWOOD CITY, Calif., March 04, 2020 (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 04, 2020 (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, 2019.\n “The recent completion of enrollment in our ongoing Phase III clinical trial, DESTINY PWS, evaluating once-daily Diazoxide Choline Controlled-Release (DCCR) tablets for patients with Prader Willi Syndrome (PWS), represents a significant achievement for our company,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “We remain on track to announce top-line data during the first half of this year, and would like to thank the patients, families and investigators involved in this study, as well as the Foundation for Prader-Willi Research (FPWR) and Prader-Willi Syndrome Association (PWSA) USA and UK for their support of DESTINY PWS.” Fourth Quarter 2019 and Recent Corporate Highlights Completed enrollment for Phase III DESTINY PWS study of DCCR Top-line data are anticipated in the first half of 2020.A total of 127 subjects were randomized at 29 sites in the US and the UK. This includes additional patients who were in screening at the time target enrollment was met.This final sample size is powered to detect a difference in change from baseline in HQ-CT score between DCCR and placebo of 4 points. The HQ-CT is a validated questionnaire to measure hyperphagia, the primary outcome measure for the Phase III study. The range of scores is 0-36, with scores above 13 typically considered to be moderate to severe hyperphagia.A blinded review of preliminary data found that the median baseline HQ-CT score for all randomized subjects is approximately 22. Treatment assignments (DCCR or Placebo) for all patients remain blinded.The duration of the open-label extension study (C602) has been increased from 12 months to up to 36 months. All subjects who have completed 12 months of open-label treatment in C602 have elected to continue to receive DCCR.No new safety signals associated with DCCR have been identified to date and no serious, unexpected adverse events related to DCCR have been reported. The Data Safety Monitoring Board (DSMB) for the Phase III DESTINY PWS recommended, for the se...