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Tonix Pharmaceuticals Announces Enrollment Initiated in the MGH Phase 2 ‘STROBE’ Study of TNX-1900 (Intranasal Potentiated Oxytocin) for the Treatment of Binge-Eating Disorder
Preliminary Data Show that Oxytocin Decreases Impulsivity and Reduces Food Intake TNX-1900 (Intranasal Potentiated Oxytocin) May Serve as a Novel
About this update from Tonix Pharmaceuticals Holding Corp.
[{"type":"text","content":"Preliminary Data Show that Oxytocin Decreases Impulsivity and Reduces Food Intake TNX-1900 (Intranasal Potentiated Oxytocin) May Serve as a Novel Neuroendocrine Treatment for Binge-Eating Disorder CHATHAM, N.J., July 31, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the investigator-initiated Phase 2 Study of The Results of Oxytocin in Binge Eating ‘STROBE’ study of TNX-1900 (intranasal potentiated oxytocin) for the treatment of binge-eating disorder at the Massachusetts General Hospital (MGH). The aim of the study is to investigate the efficacy and safety of TNX-1900 as a novel therapeutic agent to reduce binge eating frequency in adults with binge-eating disorder. Tonix is supporting the STROBE study through a clinical trial agreement with MGH. MGH is the sponsor of the trial, which is being conducted under an investigator-initiated investigational new drug (IND) application. The 8-week double-blind, placebo-controlled trial has a target enrollment of at least 60 participants 18-45 years old with binge-eating disorder. “Binge-eating disorder is identified as a reduced ability to control behavioral impulses and formed habits, disrupting the regulation of food intake and energy balance,”1-4 said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “While existing treatment options may produce remission from binge eating in some cases, up to 50% of patients continue to engage in binge eating.”5-7 Elizabeth A. Lawson, M.D., M.M.Sc., Director, Interdisciplinary Oxytocin Research Program in the Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and principal investigator of the study added, “Individuals with binge-eating disorder experience loss of control over eating that is thought to be driven by increased hedonic drive to eat as well as impulsivity.8-10 The oxytocin system has been linked to likelihood of lifetime binge eating in women11, and our preliminary studies of intranasal oxytocin at the dose used in this trial show that oxytocin modulates areas of the brain responsible for hedonic eating and impulse control12, improves impulsivity13, and reduces caloric intake.14 The goal of the STROBE study is to assess whether 8 weeks int...