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Soleno Therapeutics Provides Corporate Update and Reports Second Quarter 2022 Financial Results
REDWOOD CITY, Calif., Aug. 10, 2022 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company
About this update from Soleno Therapeutics, Inc.
[{"type":"text","content":"REDWOOD CITY, Calif., Aug. 10, 2022 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided a corporate update, and reported financial results for the three and six months ended June 30, 2022. Second Quarter 2022 and Recent Corporate Highlights U.S. Food and Drug Administration (FDA) acknowledged that data from a proposed randomized withdrawal phase of Study C602 would have the potential to address its concerns regarding the adequacy of the overall efficacy data supportive of a New Drug Application (NDA) submission for DCCR. Study C602 is an ongoing open-label extension study comprised of patients who completed DESTINY PWS, an international, multi-center, randomized, double-blind, placebo-controlled study of DCCR. The randomized withdrawal phase would consist only of participants currently enrolled in Study C602 and not include any new patients.The Company continues to work collaboratively with the FDA to finalize specific details of the study design and plans to initiate the randomized withdrawal period in the current quarter, with top-line data expected in the first quarter of 2023. Results from the analysis of caregiver interviews conducted after at least 12 months of investigational, open-label DCCR treatment showing positive changes across food- and non-food-related behaviors, as well as daily life, presented at the 11th International Prader-Willi Syndrome Organisation (IPWSO) Conference.Long-term clinical data showing improvement in metabolic parameters and body composition following treatment with DCCR tablets in patients with PWS presented at ENDO 2022.Data on the ongoing safety and efficacy of DCCR in PWS patients at presented the 2022 European Congress of Endocrinology. “We are pleased to report on a productive period, underscored by positive feedback received from the FDA regarding the planned randomized withdrawal phase of Study C602 that has the potential to support an NDA submission for DCCR ,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “Our recent presentations at scientific conferences continue to emphasize the significant potential of DCCR to be an effective and safe therapy for patients and families struggling to manage the symptoms of PWS....