Soleno Therapeutics Announces Oral Presentations featuring Diazoxide Choline Extended-Release (DCCR) Tablets in Prader-Willi Syndrome at ESPE 2024
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.
Soleno Therapeutics (NASDAQ: SLNO) ha annunciato due presentazioni orali in programma per il 62° Congresso Annuale della Società Europea di Endocrinologia Pediatrica 2024 a Liverpool, Regno Unito. Le presentazioni mostreranno dati dal loro programma di sviluppo clinico DCCR per il trattamento della sindrome di Prader-Willi (PWS). La prima presentazione si concentra sui parametri di controllo alimentare e sulla riduzione dell'iperfagia, mentre la seconda discute i risultati di efficacia a lungo termine degli studi DESTINY PWS e C602. La PWS colpisce uno ogni 15.000 nati vivi, con l'iperfagia come sintomo distintivo, che provoca una fame intensa e un comportamento di ricerca del cibo. Attualmente, non esistono terapie approvate per gli aspetti di iperfagia, metabolici, cognitivi o comportamentali della PWS.
Soleno Therapeutics (NASDAQ: SLNO) anunció dos próximas presentaciones orales en el 62º Congreso Anual de la Sociedad Europea de Endocrinología Pediátrica 2024 en Liverpool, Reino Unido. Las presentaciones mostrarán datos de su programa de desarrollo clínico DCCR para el tratamiento del síndrome de Prader-Willi (PWS). La primera presentación se centra en los parámetros de control alimentario y la reducción de la hiperfagia, mientras que la segunda discute los resultados de eficacia a largo plazo de los estudios DESTINY PWS y C602. La PWS afecta a uno de cada 15.000 nacimientos vivos, teniendo la hiperfagia como síntoma característico, lo que causa un hambre intensa y un comportamiento de búsqueda de comida. Actualmente, no hay terapias aprobadas para los aspectos de hiperfagia, metabólicos, cognitivos o de comportamiento de la PWS.
Soleno Therapeutics (NASDAQ: SLNO)는 2024년 영국 리버풀에서 열리는 제62회 유럽 소아내분비학회 연례회의에서 발표할 두 가지 구두 발표를 발표했습니다. 이 발표는 프라더-윌리 증후군 (PWS) 치료를 위한 DCCR 임상 개발 프로그램의 데이터를 보여줄 것입니다. 첫 번째 발표는 음식 조절 매개변수와 과식 감소에 중점을 두고, 두 번째 발표는 DESTINY PWS 및 C602 연구의 장기적 효능 결과에 대해 논의합니다. PWS는 15,000명의 출생 중 1명에게 영향을 미치며, 과식이 주요 증상으로 나타나며, 강한 배고픔과 음식을 찾는 행동을 유발합니다. 현재 PWS의 과식, 대사, 인지 또는 행동 측면에 대한 승인된 치료법은 없습니다.
Soleno Therapeutics (NASDAQ: SLNO) a annoncé deux présentations orales à venir lors du 62e Congrès Annuel de la Société Européenne d'Endocrinologie Pédiatrique 2024 à Liverpool, au Royaume-Uni. Les présentations mettront en avant des données de leur programme de développement clinique DCCR pour le traitement du syndrome de Prader-Willi (PWS). La première présentation est axée sur les paramètres de contrôle alimentaire et la réduction de l'hyperphagie, tandis que la seconde discute des résultats d'efficacité à long terme des études DESTINY PWS et C602. Le PWS touche une naissance sur 15 000, l'hyperphagie étant son symptôme distinctif, provoquant une faim intense et un comportement de recherche de nourriture. Actuellement, il n'existe aucune thérapie approuvée pour les aspects d'hyperphagie, métaboliques, cognitifs ou comportementaux de la PWS.
Soleno Therapeutics (NASDAQ: SLNO) kündigte zwei bevorstehende mündliche Präsentationen auf dem 62. Jahreskongress der Europäischen Gesellschaft für Pädiatrische Endokrinologie 2024 in Liverpool, Großbritannien, an. Die Präsentationen werden Daten aus ihrem klinischen Entwicklungsprogramm DCCR zur Behandlung des Prader-Willi-Syndroms (PWS) präsentieren. Die erste Präsentation konzentriert sich auf Lebensmittelkontrollparameter und die Reduzierung von Hyperphagie, während die zweite die langfristigen Wirksamkeitsergebnisse aus den Studien DESTINY PWS und C602 erörtert. PWS betrifft eins von 15.000 Lebendgeburten, wobei Hyperphagie das Hauptsymptom ist, das intensiven Hunger und Nahrungsverlangen verursacht. Derzeit gibt es keine zugelassenen Therapien für die Hyperphagie sowie für die metabolischen, kognitiven oder verhaltensbezogenen Aspekte von PWS.
- 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
- None.
Insights
This conference presentation announcement about DCCR trials in Prader-Willi Syndrome (PWS) lacks immediate market-moving significance. While the research is important for SLNO's development pipeline, conference presentations typically share already-known data rather than reveal new breakthrough results. The presentations will focus on previously completed C601 and C602 trials, discussing food control parameters and long-term efficacy.
The PWS market represents a significant unmet medical need, with no approved therapies for hyperphagia management. With PWS affecting 1 in 15,000 live births and
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 62nd 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:
| 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,
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
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