Soleno Therapeutics Announces Multiple Presentations at the 2025 United in Hope: International Prader-Willi Syndrome Conference
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Insights
Soleno will present promising DCCR data for Prader-Willi syndrome at a major international conference, advancing their rare disease therapeutic profile.
Soleno Therapeutics is significantly expanding the clinical evidence supporting their lead drug candidate DCCR (diazoxide choline extended-release) tablets for Prader-Willi syndrome (PWS) with seven presentations at the upcoming international conference. The data being presented comes from their completed DESTINY PWS study and open-label extension, covering critical aspects of the drug's performance.
The presentations focus on several clinically meaningful outcomes including long-term efficacy, hyperphagia reduction even in strictly food-controlled patients, and safety/efficacy in patients with pre-diabetes or diabetes. Perhaps most significant is the data comparing changes in fat mass between DCCR-treated participants and those in the NIH Natural History Study, suggesting the treatment may positively impact body composition.
The conference timing is strategic as it represents an unprecedented collaboration between three major PWS advocacy organizations and is expected to be the largest PWS-focused gathering ever held. This gives Soleno an optimal platform to showcase their data to key opinion leaders, researchers, and the patient community.
The presentations specifically addressing hyperphagia (excessive hunger) are particularly noteworthy as this is one of the most debilitating aspects of PWS. Data showing DCCR's ability to reduce hyperphagia, especially in patients already under strict food controls, suggests the drug may address a fundamental need not met by behavioral interventions alone. Additionally, the presentation on relaxation of food control parameters based on improvements in the Food Safe Zone Questionnaire indicates potential quality-of-life benefits beyond the primary endpoints.
For a rare disease biotech company, establishing a strong presence at the field's definitive conference strengthens their scientific credibility and market positioning as they advance toward potential commercialization of DCCR for PWS.
Conference is the first-ever international meeting jointly hosted by the Prader-Willi Syndrome Association | USA, the Foundation for Prader-Willi Research, and the International Prader-Willi Syndrome Organisation
REDWOOD CITY, Calif., June 20, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced one oral and six poster presentations at the 2025 United In Hope: International Prader-Willi Syndrome Conference, which will be held June 24-28, 2025, in Phoenix, AZ.
The conference represents a unique collaboration between the Prader-Willi Syndrome Association | USA (PWSA | USA), the Foundation for Prader-Willi Research (FPWR), and the International Prader-Willi Syndrome Organisation (IPWSO), and is anticipated to be the largest conference focused on Prader-Willi syndrome (PWS) ever held.
“At Soleno, we are reminded every day of the vital role that data, science, and advocacy play in driving meaningful progress for rare disease communities. In this 50th anniversary year of the founding of the first PWS group, PWSA | USA, we are particularly reminded of this progress,” said Dr. Anish Bhatnagar, Chief Executive Officer and Chairman of the Board of Soleno Therapeutics. “In a condition like PWS, where the lived experience of individuals with PWS and their families is essential to understanding the full impact of the disease, our partnership with advocacy groups is critical. We are honored to have a strong presence at this year’s International PWS Conference and remain deeply committed to advancing research, listening to the community, and working together to improve the lives of those impacted by PWS.”
Presentation details:
| Format: oral presentation | |
| 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 |
| Presenter: | Evelien Gevers MD, PhD, Consultant, Queen Mary University of London, Barts and The London Medical School, William Harvey Research Institute, Centre for Endocrinology, London, UK, Barts Health NHS Trust Royal London Hospital, London UK |
| Date/time: | Thursday, June 26, 11:00 MST |
| Format: poster presentations | |
| Title: | Swallowability and Dosing Compliance of Diazoxide Choline Extended-Release (DCCR) Tablets in Patients with Prader-Willi Syndrome |
| Presenter: | Neil Cowen, PhD, MBA, Senior Vice President, Drug Development, Soleno Therapeutics |
| Date/time: | Wednesday, June 25, 4:00-6:00 MST |
| Title: | Diazoxide Choline Extended-Release (DCCR) Tablets Significantly Reduce Hyperphagia in Patients with PWS Who Are Managed with Strict Food Controls |
| Presenter: | Evelien Gevers MD, PhD, Consultant, Queen Mary University of London, Barts and The London Medical School, William Harvey Research Institute, Centre for Endocrinology, London, UK, Barts Health NHS Trust Royal London Hospital, London UK |
| Date/time: | Wednesday, June 25, 4:00-6:00 MST |
| Title: | The Emotional Impact of Hyperphagia: Insights from the PWS Community |
| Presenter: | Maria Picone, Founder and CEO, TREND Community |
| Date/time: | Wednesday, June 25, 4:00-6:00 MST |
| Title: | Safety and Efficacy of Diazoxide Choline Extended-Release (DCCR) Tablets in Patients with PWS who have Pre-Diabetes or Diabetes |
| Presenter: | Jennifer Miller, MD, Professor of Pediatric Endocrinology, the University of Florida, Gainesville |
| Date/time: | Wednesday, June 25, 4:00-6:00 MST |
| Title: | Comparison of Changes in Fat Mass in Participants with PWS Treated with Diazoxide Choline Extended-Release (DCCR) Tablets to Those in the NIH Natural History Study |
| Presenter: | Jennifer Miller, MD, Professor of Pediatric Endocrinology, the University of Florida, Gainesville |
| Date/time: | Wednesday, June 25, 4:00-6:00 MST |
| 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) Tablets in Participants with Prader-Willi Syndrome |
| Presenter: | Evelien Gevers MD, PhD, Consultant, Queen Mary University of London, Barts and The London Medical School, William Harvey Research Institute, Centre for Endocrinology, London, UK, Barts Health NHS Trust Royal London Hospital, London UK |
| Date/time: | Wednesday, June 25, 4:00-6:00 MST |
For additional information about the conference, please see: https://www.pwsausa.org/2025-united-in-hope-conference/
About PWS
Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15.
The Prader-Willi Syndrome Association | USA estimates that PWS occurs in one in every 15,000 live births. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterized by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. 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.
About Soleno Therapeutics, Inc.
Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s first commercial product, VYKAT™ XR (diazoxide choline) extended-release tablets, formerly known as DCCR, is a once-daily oral treatment for hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome and was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025. 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 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
Media Contact:
media@soleno.life
FAQ
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