Tonix Pharmaceuticals doses first patient in MGH-Led FOCUS study of intranasal Oxytocin therapy

Proactive - Interviews for investors

Tonix Pharmaceuticals Holdings CEO Dr. Seth Lederman joined Steve Darling from Proactive to announce that the first patient has been dosed in the investigator-initiated FOCUS study at Massachusetts General Hospital. The study is focused on adult patients with arginine-vasopressin deficiency (AVP-D)—a rare endocrine disorder formerly known as central diabetes insipidus—that is now understood to be linked to oxytocin deficiency and adverse mental health outcomes. Dr. Lederman explained that oxytocin, commonly known as the “bonding hormone,” plays a critical role in regulating mood, social behavior, and emotional wellbeing. Emerging evidence suggests that individuals with AVP-D suffer from low oxytocin levels, contributing to symptoms such as anxiety, depression, and socioemotional impairment. The FOCUS study is designed as a randomized, double-blind, placebo-controlled crossover pilot trial. It will assess Tonix’s investigational intranasal potentiated oxytocin formulations—TNX-1900 (24 IU) and TNX-2900 (6 IU)—to determine their impact on mood and social functioning markers in patients with AVP-D. In addition to the single-dose evaluations, the study will include an exploratory two-week treatment phase to assess longer-term effects on mental health and quality-of-life outcomes. Dr. Lederman noted that Tonix is providing study support and that results from this research may inform the broader development of oxytocin replacement therapies for neuropsychiatric and endocrine-related disorders. The successful dosing of the first patient marks a significant milestone in Tonix’s ongoing efforts to advance innovative, mechanism-driven therapies for complex disorders with unmet medical needs. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #Biotech #MPOXVaccine #Smallpox #TNX801 #VaccineDevelopment #ClinicalTrials #PharmaceuticalNews #MedicalResearch #WHO #GlobalHealth #InfectiousDiseases #Biopharma #ProactiveInvestors