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Soleno Therapeutics Announces Positive Outcome from Second Planned Data Safety Monitoring Board Review of Phase III DESTINY PWS Clinical Trial of DCCR in Prader-Willi Syndrome
REDWOOD CITY, Calif., Oct. 02, 2019 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel
About this update from Soleno Therapeutics, Inc.
[{"type":"text","content":"REDWOOD CITY, Calif., Oct. 02, 2019 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the Data Safety Monitoring Board (DSMB) has, for the second time, recommended the continuation without modification of the Company’s Phase III trial in Prader-Willi Syndrome (PWS) patients, DESTINY PWS. The outcome of this second planned meeting was based on the review of data from more than 50% of patients enrolled and treated.\n “We are pleased to again receive the DSMB’s recommendation to continue the Phase III trial as planned and without modification, which provides ongoing support of DCCR’s safety profile,” said Dr. Anish Bhatnagar, Chief Executive Officer of Soleno. “Enrollment in DESTINY PWS remains on track for the availability of top-line data in the first half of 2020.” DESTINY PWS is a Phase III, randomized, double-blind, placebo-controlled study of once daily oral administration of DCCR versus placebo in approximately 100 patients with a confirmed diagnosis of PWS. The primary endpoint is change from baseline hyperphagia score at Week 13. Patients who complete DESTINY PWS have the option to enroll into C602, the open-label safety extension study. The DSMB is a group of independent experts monitoring the safety of DESTINY PWS. The DSMB reviews safety information and can make recommendations to either continue the study without modification, modify the study or terminate the study due to safety concerns. In July 2018, the U.S. Food and Drug Administration designated the investigation of DCCR for the treatment of PWS to be a Fast Track development program. Prior to this, diazoxide choline received orphan designation for the treatment of PWS in the U.S. and in the E.U. For further information about the trial (NCT03440814), please visit: www.clinicaltrials.gov. About PWSThe Prader-Willi Syndrome Association USA estimates that one in 12,000 to 15,000 people in the U.S. have PWS. The hallmark symptom of this disorder is hyperphagia, a chronic feeling of insatiable hunger that severely diminishes the quality of life for PWS patients and their families. Additional characteristics of PWS include behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth ho...