Soleno Therapeutics Announces Oral Presentations featuring Diazoxide Choline Extended-Release (DCCR) Tablets in Prader-Willi Syndrome at ESPE 2024

Rhea-AI Summary

Soleno Therapeutics (NASDAQ: SLNO) announced two upcoming oral presentations at the 62nd Annual European Society for Paediatric Endocrinology Meeting 2024 in Liverpool, UK. The presentations will showcase data from their DCCR clinical development program for Prader-Willi syndrome (PWS) treatment. The first presentation focuses on food control parameters and hyperphagia reduction, while the second discusses long-term efficacy results from the DESTINY PWS and C602 studies. PWS affects one in 15,000 live births, with hyperphagia as its hallmark symptom, causing intense hunger and food-seeking behavior. Currently, there are no approved therapies for PWS's hyperphagia, metabolic, cognitive, or behavioral aspects.

Positive

• Clinical trial data presentation at major medical conference indicates progress in drug development
• Addressing an unmet medical need with no current approved therapies
• Targeting a rare disease affecting 1 in 15,000 live births

Negative

• None.

REDWOOD CITY, Calif., Nov. 14, 2024 (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 it will be presenting data from its DCCR clinical development program for the treatment of Prader-Willi syndrome (PWS) at the 62^nd Annual European Society for Paediatric Endocrinology (ESPE) Meeting 2024, being held November 16-18, 2024 in Liverpool, UK.

Details of the oral presentations are as follows:

ESPE 2024

Title:	Relaxation of Food Control Parameters Based on Improvements in the Food Safe Zone Questionnaire Occurs with Reduction of Hyperphagia in Clinical Trials of Diazoxide Choline Extended-Release (DCCR) in Participants with Prader-Willi Syndrome
Format:	Oral Presentation
Session:	Free Communications 6: Fat, Metabolism and Obesity (1)
Date/Time:	Sunday, November 17, 2024 at 10:30 AM GMT
Presenter:	Nicola Bridges, M.D. (Chelsea and Westminster Hospital NHS Trust, London, UK)

Title:	Long-term Efficacy Results of Diazoxide Choline Extended-Release (DCCR) Tablets in Participants with Prader-Willi Syndrome from the Completed C601 (DESTINY PWS) and C602 Open Label Extension (OLE) Studies
Format:	Oral Presentation
Session:	Free Communications 11: Fat, Metabolism and Obesity (2)
Date/Time:	Monday, November 18, 2024 at 10:00 AM GMT
Presenter:	Evelien Gevers, M.D., Ph.D. (Queen Mary University of London, Barts and The London Medical School, William Harvey Research Institute, Centre for Endocrinology; Parts Health NHS Trust, Royal London Hospital, UK)

About PWS
The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The hallmark symptom of this disorder is hyperphagia, a chronic and life-threatening condition characterized by feelings of intense, persistent hunger, food pre-occupation, and an extreme drive to seek and consume food, which can severely diminish the quality of life for individuals with PWS 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 mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease. In a global survey conducted by the Foundation for Prader-Willi Research, 96.5% of respondents (parents and caregivers) rated hyperphagia and 92.9% rated body composition as either 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.

About DCCR (Diazoxide Choline) Extended-Release Tablets
DCCR is a novel, proprietary extended-release dosage form containing diazoxide choline, the crystalline salt of diazoxide and is administered once-daily. The parent molecule, diazoxide, has been used for decades in thousands of individuals in a few rare diseases in neonates, infants, children and adults, but is not approved for use in PWS. Soleno conceived of and established extensive patent protection for the therapeutic use of diazoxide, diazoxide choline and DCCR in individuals 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 individuals with PWS. In the PWS Phase 3 clinical development program, 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. An NDA for its lead candidate, DCCR (diazoxide choline) extended-release tablets, a once-daily oral tablet for the treatment of Prader-Willi syndrome (PWS) is currently under review by the FDA and was granted Priority Review. 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 the 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 the FDA’s review of our NDA, 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 will Soleno Therapeutics (SLNO) present at ESPE 2024?

Soleno Therapeutics will present two oral presentations on DCCR tablets for Prader-Willi syndrome treatment, focusing on food control parameters and long-term efficacy results from the DESTINY PWS and C602 studies.

When and where will Soleno Therapeutics (SLNO) present their DCCR data?

The presentations will take place at the ESPE Meeting 2024 in Liverpool, UK, on November 17 and 18, 2024.

What is the market opportunity for Soleno Therapeutics' (SLNO) DCCR treatment?

DCCR targets Prader-Willi syndrome, which affects 1 in 15,000 live births, with no currently approved therapies for hyperphagia, metabolic, cognitive, or behavioral aspects of the disorder.