Soleno Therapeutics Participates in Prader-Willi Syndrome (PWS) DCCR Town Hall

Rhea-AI Summary

Soleno Therapeutics (NASDAQ: SLNO) announced CEO Anish Bhatnagar's participation in a Prader-Willi Syndrome (PWS) DCCR Town Hall on April 14, 2021. The event highlighted the unmet medical needs of PWS patients and the company's commitment to obtaining regulatory approval for DCCR. Bhatnagar discussed insights from the Foundation for Prader-Willi Research regarding patient experiences in clinical trials. DCCR, a novel treatment for PWS, is currently in Phase 3 trials and has received Orphan Drug and Fast Track Designation in the U.S. and EU.

Positive

• DCCR has shown promise in treating hyperphagia and other symptoms of PWS.
• The treatment has received Orphan Drug Designation and Fast Track Designation.

Negative

• No approved therapies currently exist for PWS, indicating competitive pressure for DCCR.
• Regulatory approval for DCCR remains uncertain, posing risks for investors.

REDWOOD CITY, Calif., April 14, 2021 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that Anish Bhatnagar, M.D., Chief Executive Officer, participated in a Prader-Willi Syndrome (PWS) DCCR Town Hall on Wednesday, April 14, 2021.

The event featured speakers from the PWS community who discussed the challenges of living with PWS, as well as patient and caregiver perspectives on DCCR treatment.

Dr. Bhatnagar’s remarks highlighted the unmet medical needs facing PWS patients, the Company’s ongoing commitment to obtaining regulatory approval for DCCR and an outline of the necessary steps to obtain regulatory approval. The remarks have been published as an open letter to the PWS community, which can be accessed here: https://investors.soleno.life/events-and-presentations/event-calendar.

In addition, Dr. Bhatnagar referenced the work completed by the Foundation for Prader-Willi Research and Prader-Willi Syndrome Association | USA in collecting the experiences of patients and caregivers during the completed DESTINY PWS Phase III clinical trial and in the ongoing C602 open-label study. This information was compiled by these organizations and sent together with a letter to the U.S. Food and Drug Administration on DCCR. Further information can be found by visiting their respective websites: www.fpwr.org and www.pwsusa.org.

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., obesity, diabetes, cardiovascular disease) and mortality (e.g., stomach rupture, 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.

About DCCR (Diazoxide Choline) Extended-Release Tablets
DCCR is a novel, proprietary extended-release dosage form containing the crystalline salt of diazoxide and 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 diazoxide and DCCR in patients with PWS. 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, one of which was in PWS patients. In the PWS Phase 3 study, DCCR showed promise in addressing hyperphagia, the hallmark symptom of PWS, as well as several other symptoms such as aggressive/destructive behaviors, fat mass and other metabolic parameters.

About Soleno Therapeutics, Inc.
Soleno is focused on the development and commercialization of novel therapeutics 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 Phase 3 clinical development program. For more information, please visit www.soleno.life.

Forward-Looking Statements
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 timing of any regulatory process or ultimate approvals and determining a path forward for DCCR for the treatment of PWS. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar 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 risks and uncertainties inherent in Soleno’s business, including those described in the company's prior press releases and in the periodic reports it files with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could 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 any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Corporate Contact:
Brian Ritchie
LifeSci Advisors, LLC
212-915-2578

FAQ

What is the significance of the DCCR Town Hall event for SLNO?

The DCCR Town Hall event highlighted Soleno's commitment to addressing the unmet needs of PWS patients and reinforced its efforts toward regulatory approval.

What are the current developments regarding DCCR and SLNO?

DCCR is in a Phase 3 clinical trial stage, focusing on treating PWS, with promising results related to hyperphagia.

What designations has DCCR received for PWS treatment?

DCCR has received Orphan Drug Designation and Fast Track Designation in the U.S. and EU.

How does DCCR address the symptoms of Prader-Willi Syndrome?

DCCR aims to alleviate hyperphagia and other metabolic and behavioral symptoms associated with PWS.

What challenges does Soleno face in gaining approval for DCCR?

Soleno faces uncertainties regarding regulatory approval processes and the competitive landscape with no existing therapies for PWS.