Soleno Therapeutics provides regulatory update on DCCR for
REDWOOD CITY, Calif., Jan. 24, 2022 (GLOBE NEWSWIRE) — Soleno Therapeutics, Inc. (Soleno or the Company) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapies for the treatment of rare diseases, has today provided an update following recent interactions with the U.S. Food and Drug Administration (FDA) regarding the development of once-daily DCCR (diazoxide choline) extended-release tablets for the treatment of of Prader-Willi (PWS).
On January 20, 2022, the Company received the formal minutes of the December 21, 2021 Type C meeting with the FDA Division of Psychiatry. The purpose of the meeting was to discuss the adequacy of data submitted by Soleno to the FDA in October 2021 to support a potential New Drug Application (NDA) submission for DCCR for the treatment of PWS, as well as possible ways generate clinical data. The FDA has indicated that it is open to a study design involving participants currently enrolled in Study C602, the company’s ongoing open-label extension study to generate the additional control data needed to support a NDA. The Company expects to submit a study proposal shortly and, if acceptable, intends to initiate the study thereafter.
“We appreciate the constructive dialogue with the FDA and the opportunity to obtain additional controlled clinical data from participants already enrolled in C602. This approach would significantly reduce the time and cost of obtaining the necessary data,” said Anish Bhatnagar, MD, CEO of Soleno Therapeutics. “It is important to note that we are continuing our preparations for an NDA submission for the DCCR while additional data is collected.”
Study C602 is an open-label extension study of patients who have completed DESTINY PWS, an international, multicenter, randomized, double-blind, placebo-controlled study in DCCR.
The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births in the United States. The hallmark symptom of this disorder is binge eating, a chronic feeling of insatiable hunger that dramatically diminishes the quality of life of PWS patients and their families. Additional features of PWS include behavioral problems, cognitive impairment, low muscle tone, short stature (when not treated with growth hormone), accumulation of excess fat body, developmental delays and incomplete sexual development. Overeating can lead to significant morbidity (eg, obesity, diabetes, cardiovascular disease) and mortality (eg, stomach rupture, choking, accidental death due to foraging behavior). In a global survey conducted by the Prader-Willi Research Foundation, 96.5% of respondents (parents and caregivers) rated binge eating and 92.9% rated body composition as the most important or very important symptom to relieve with a new drug. There are currently no approved therapies to address the overeating/appetite, metabolic function, cognitive function, or behavioral aspects of the disorder. Diazoxide choline has received orphan drug designation for the treatment of PWS in the US and EU, and Fast Track designation in the US
About DCCR (diazoxide choline) sustained-release tablets
DCCR is a new proprietary extended release dosage form containing the crystalline salt of diazoxide and is administered once daily. The parent drug, diazoxide, has been used for decades in thousands of patients with a few rare diseases in neonates, infants, children, and adults, but has not been approved for use in PWS . Soleno has designed and established extensive patent protection on the therapeutic use of diazoxide and DCCR in PWS patients. The DCCR development program is supported by data from five completed Phase 1 clinical studies in healthy volunteers and three completed Phase 2 clinical studies, including one in patients with PWS. In the Phase 3 PWS study, DCCR showed promise for treating overeating, the hallmark symptom of PWS, as well as several other symptoms such as aggressive/destructive behaviors, fat mass, and others. metabolic parameters.
About Soleno Therapeutics, Inc.
Soleno focuses on the development and commercialization of new therapies for the treatment of rare diseases. The company’s lead candidate, DCCR extended-release tablets, a once-daily oral tablet for the treatment of Prader-Willi Syndrome (PWS), is currently being evaluated in a development program phase 3 clinical. For more information, visit www.soleno.life.
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the timing of any regulatory processes or final approvals and determination of a path forward for DCCR to address of the PWS. In some cases, you can identify forward-looking statements by words such as “may”, “will”, “should”, “expect”, “plan”, “anticipate”, “could”, ” intends”, “targets”, “”plans”, “intends”, “believes”, “estimates”, “predicts”, “potential” or “continues” or the negative form of these terms or other expressions These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties associated with market conditions, as well as the risks and uncertainties inherent in Soleno’s business, including those described in the company’s prior press releases and periodic reports it files with the SEC Events and circumstances reflected in the company’s forward-looking statements may not be realized or occur and actual results may differ materially from those projected in the forward-looking statements. Except as required by applicable law, the Company does not plan to publicly update or revise the forward-looking statements contained herein, whether as a result of new information, future events, changed circumstances or others.
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