Somapacitan

June 28, 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 the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS) in individuals four years and older who have hyperphagia. “Submission of the DCCR NDA to the FDA marks a significant milestone not only for Soleno, but for people living with PWS,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “This regulatory submission advances us one important step closer to our goal of bringing to market a new therapeutic for individuals with PWS that addresses the life-threatening hyperphagia and other key aspects of this serious and rare condition. We look forward to working with the FDA throughout the review process. We extend sincere gratitude to the team at Soleno, investigators, study site teams, advocacy organizations and most importantly, the individuals with PWS and their families who were instrumental in completing our DCCR development program.” DCCR has Breakthrough and Fast Track Designations in the U.S., as well as Orphan Drug Designation for PWS in the U.S. and E.U. The FDA has 60 days to determine whether the NDA is accepted for review. Soleno has requested Priority Review of the NDA, which would provide a target review period of six months by the FDA after the NDA has been accepted. 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 feeling of intense, persistent hunger, food pre-occupation, extreme drive to food seek and consume food that 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, 96.5% of respondents (parents and caregivers) rated hyperphagia and 92.9% rated body composition as either 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. 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. Diazoxide choline has received Orphan Drug Designation for the treatment of PWS in the U.S. and E.U., and Fast Track and Breakthrough Designations in the U.S. Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company recently submitted an NDA to the FDA, supported by its Phase 3 development program, for its lead candidate, DCCR (diazoxide choline) extended-release tablets, a once-daily oral tablet for the treatment of Prader-Willi syndrome (PWS). For more information, please visit www.soleno.life. The content above comes from the network. if any infringement, please contact us to modify.

SHENZHEN, China, May 30, 2024 /PRNewswire/ -- On the 24th of May, Kexing Biopharm (688136.SH) announced that Shenzhen Kexing Pharmaceutical Co., Ltd., its wholly-owned subsidiary, recently received a Notice of Approval for Drug Clinical Trials from the National Medical Products Administration, approving its clinical trial application for GB08 injection solution developed independently by the company. GB08 was developed using recombinant DNA technology, where the human growth hormone (hGH) gene was linked to a human IgG4-Fc segment gene for expression. GB08 shows significantly improved product safety, patience convenience and compliance. This product is the first Class I innovative drug independently developed by Kexing Biopharm since its listing on the STAR Market. It is a long-acting growth hormone developed to fulfill the clinical needs of patients with pediatric growth hormone deficiency syndrome. There are no long-acting growth hormone products in Fc-fusion format available in the current market. Hence, if launched successfully in the future, this product is expected to provide a new treatment option for pediatric patients with growth hormone deficiency syndrome. Developed by Kexing Biopharm, GB08 is a long-acting growth hormone in the form of a Fc-fusion protein, representing a brand-new generation of long-acting protein drugs. Kexing Biopharm has delved into the R&D of recombinant protein drugs for over 20 years. In its R&D pipeline, a short-acting growth hormone received clinical trial approval last year, and the recent approval of the long-acting version of growth hormone for clinical trials signals another breakthrough for the company in the development of innovative drugs. This achievement not only helps Kexing Biopharm to further optimize its product structure, but it also marks an era when Kexing Biopharm has officially entered the long-acting growth hormone market through fully independent R&D. This accomplishment has also brought hope to patients worldwide, and Kexing Biopharm will leverage this product to tap the vast market potential for long-term profitability. Against the backdrop of a significant demand gap for long-acting growth hormone products globally, the approval of Kexing Biopharm's clinical trial application for GB08 injection solution is of positive significance for the company's future development. It will particularly contribute to the "for global" strategy Kexing Biopharm has been promoting in recent years. SOURCE Kexing Biopharm