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Tonix Pharmaceuticals Announces Enrollment Initiated in Mass General Brigham Phase 2 Investigator-Initiated Study of TNX-1900 (Intranasal Potentiated Oxytocin) for Bone Health in Children with Autism Spectrum Disorder
Children with Autism Spectrum Disorder are at Risk for Low Bone Density Preliminary Data Suggest that the Administration of Oxytocin May Favorably Impact Bone
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Children with Autism Spectrum Disorder are at Risk for Low Bone Density Preliminary Data Suggest that the Administration of Oxytocin May Favorably Impact Bone Formation and Strength Recent Meta-Analysis Reported that Plasma Oxytocin Levels Tend to be Lower in Children with Autism Spectrum Disorder than Controls1 CHATHAM, N.J., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the first participant was enrolled in an investigator-initiated Phase 2 study of TNX-1900 (intranasal potentiated oxytocin) for improving bone health in children with autism spectrum disorder (ASD), named the BOX study, at Massachusetts General Hospital (MGH). The aim of this Department of Defense-funded study is to investigate the efficacy and safety of TNX-1900 as a novel therapeutic agent to increase bone density and improve bone structure and strength in children with ASD. Tonix is providing active drug and placebo for the BOX study as part of a drug donation agreement with MGH. MGH is the sponsor of the trial, which is being conducted under an investigator-initiated investigational new drug (IND) application. “Low bone density in ASD is a serious problem,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Intranasal potentiated oxytocin is a potential treatment option that addresses the biology of bone loss specific to ASD which is different from osteoporosis in post-menopausal women. Intranasal oxytocin has a long history of being tested for the treatment of ASD, but results have been inconsistent. Tonix’s magnesium-potentiated intranasal oxytocin is designed to improve consistency in clinical effects, because it reduces the ‘high-dose’ inhibition seen in the ‘inverted U’ dose response in animals.”2 Madhusmita Misra, M.D., MPH, Chief, Division of Pediatric Endocrinology, Department of Pediatrics, Mass General for Children, and principal investigator of the study said, “The childhood and adolescent years are critical for bone mass accrual towards achievement of peak bone mass, a key determinant of future bone health and fracture risk. Preliminary data show that over a four-year period, children with ASD fail to catch-up with typically developing children f...