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Soleno Therapeutics Receives Orphan Drug Designation from FDA for Diazoxide Choline for the Treatment of Glycogen Storage Disease Type 1a
REDWOOD CITY, Calif., June 02, 2021 (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., June 02, 2021 (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 the U.S. Food and Drug Administration (FDA) has granted its investigational drug, DCCR (diazoxide choline) Extended-Release tablets, Orphan Drug Designation for the treatment of Glycogen Storage Disease Type 1a (GSD 1a), or von Gierke disease. DCCR previously received Orphan Drug Designation for the treatment of Prader-Willi syndrome. “The granting of Orphan Drug Designation for our DCCR program in an additional indication, GSD 1a, represents a significant milestone for Soleno,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “GSD 1a is a type of glycogen storage disease marked by the body’s inability to metabolize glycogen into glucose, resulting in hypoglycemia, high levels of fat in the blood, and impaired growth, among other complications. We believe DCCR’s mechanism of action as an ATP-dependent potassium channel agonist, with the potential to regulate hypoglycemia and reduce fatty acid synthesis, could provide a meaningful treatment option for GSD 1a, a condition for which there are currently no approved therapies.” The FDA's Office of Orphan Drug Products grants Orphan Drug Designation to support drug candidates in development for underserved patient populations or rare disorders that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies a candidate for various development incentives, including tax credits for eligible clinical trials, waiver of application fees and market exclusivity for seven years upon FDA approval. 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, DCCR Extended-Release tablets, a once-daily oral tablet, is currently being evaluated in a Phase 3 clinical development program for the treatment of Prader-Willi syndrome (PWS). No clinical development program is underway for GSD 1a. For more information, please visit www.soleno.life. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934,...