Soleno Therapeutics Provides Regulatory Update on DCCR for the Treatment of Prader-Willi Syndrome

Soleno intends to submit plans to FDA to conduct further analyses of clinical data from completed and ongoing studies of DCCR, together with external, natural history studies

REDWOOD CITY, Calif., Dec. 11, 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 the receipt of official meeting minutes from the November 12, 2020, Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the development of once-daily Diazoxide Choline Controlled Release (DCCR) tablets for the treatment of Prader-Willi Syndrome (PWS). The meeting minutes confirmed the discussion with the FDA regarding the potential adequacy of data from completed and ongoing studies with DCCR, together with external, natural history studies to support a New Drug Application (NDA) for DCCR for the treatment of PWS. Soleno intends to submit formal plans for these analyses, which the FDA has stated it is committed to reviewing.

“We appreciate the guidance provided by the FDA and are finalizing our plans to conduct the analyses that were discussed at this meeting and look forward to submitting them to the FDA,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “While we hope that these data, together with the additional analyses, will suffice as adequate for an NDA, we cannot, at this time, exclude the possibility that the FDA will require us to conduct an additional controlled clinical study. We look forward to working with the FDA to ensure that the necessary data and information are compiled for the NDA, which we are currently preparing to submit in the second half of 2021.”

About PWS
The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births in the U.S. 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 hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development. Hyperphagia can lead to significant morbidities (e.g., stomach rupture, obesity, diabetes, cardiovascular disease) and mortality (e.g., choking, accidental death due to food seeking behavior). In a global survey conducted by the Foundation for Prader-Willi Research, 96.5% of respondents (parent and caregivers) rated hyperphagia as the most important or a very important symptom to be relieved by a new medicine. There are currently no approved therapies to treat the hyperphagia/appetite, metabolic, cognitive function, or behavioral aspects of the disorder. Diazoxide choline has received Orphan Drug Designation for the treatment of PWS in the U.S. and EU, and Fast Track Designation in the U.S.