Soleno Therapeutics Announces Late-Breaking Oral Presentation with Body Composition Results from Phase III DESTINY PWS Trial of DCCR in Prader-Willi Syndrome at ObesityWeek® 2020 Meeting

Rhea-AI Summary

Soleno Therapeutics (NASDAQ: SLNO) announced that body composition data from its Phase III trial, DESTINY PWS, will be presented at ObesityWeek® 2020. The presentation focuses on DCCR tablets for treating Prader-Willi Syndrome (PWS) and is scheduled for November 3, 2020. PWS is a rare genetic disorder affecting one in 15,000 births, characterized by insatiable hunger and related health complications. DCCR has received Orphan Drug and Fast Track Designation in the U.S. for PWS. Currently, there are no approved treatments for this condition, making DCCR's development critical.

Positive

• DCCR tablets have received Orphan Drug Designation in the U.S. and EU.
• DCCR has received Fast Track Designation in the U.S.
• DCCR shows promise in addressing the hallmark symptom of PWS, hyperphagia.

Negative

• None.

REDWOOD CITY, Calif., Oct. 29, 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 that body composition data from the Company’s Phase III trial, DESTINY PWS (C601), evaluating once-daily Diazoxide Choline Controlled Release (DCCR) tablets for patients with Prader-Willi Syndrome (PWS), will be highlighted in a late-breaking oral presentation at The Obesity Society’s ObesityWeek® 2020 meeting, being held virtually from November 2-6, 2020. The data will be presented by Parisa Salehi, M.D., Clinical Director of the Prader-Willi Syndrome Clinic at Seattle Children’s Hospital.

Details of the presentation are below:

Abstract Title:	A Phase III Study of DCCR in Prader-Willi Syndrome: Effects on Body Composition and Adipokines
Presenter:	Parisa Salehi, M.D., Seattle Children’s Hospital
Session:	Oral 002/Track 3: Interventional and Clinical Studies
Date/Time:	Tuesday, November 3, 2020, 9:45 AM – 10:00 AM ET

The abstract is available on the ObesityWeek website and can be accessed directly here.

About PWS
The Prader-Willi Syndrome Association USA and the Foundation for Prader-Willi Research estimate that PWS occurs in approximately one in every 15,000 live births. 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.

About Diazoxide Choline Controlled-Release (DCCR) Tablet
Diazoxide Choline Controlled-Release tablet is a novel, proprietary extended-release, crystalline salt formulation of diazoxide, which 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 I clinical studies in healthy volunteers and three completed Phase II clinical studies, one of which was in PWS patients. In the PWS Phase II 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, Diazoxide Choline Controlled-Release (DCCR) tablets, a once-daily oral tablet for the treatment of Prader-Willi Syndrome (PWS), is currently being evaluated in a Phase III 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. 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 focus of the Phase III DESTINY PWS trial by Soleno Therapeutics?

The trial evaluates DCCR tablets for treating Prader-Willi Syndrome.

When will the body composition data from the DESTINY PWS trial be presented?

The data will be presented on November 3, 2020, during ObesityWeek 2020.

What designations has DCCR received for treating Prader-Willi Syndrome?

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

How common is Prader-Willi Syndrome?

PWS occurs in approximately one in every 15,000 live births.

What is the hallmark symptom of Prader-Willi Syndrome?

The hallmark symptom is hyperphagia, or insatiable hunger.