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Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated biotechnology company with marketed products and a pipeline of development candidates, today announced that the first patient has been dosed in the investigator-initiated FOCUS study (NCT04789148) at Massachusetts General Hospital (MGH) in adult patients with arginine-vasopressin deficiency (AVP-D), a rare endocrine disorder associated with oxytocin deficiency and adverse mental health outcomes, formerly known as central diabetes insipidus.
"Patients with AVP-D often experience mental health and quality-of-life challenges that are not adequately addressed by current interventions," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "Oxytocin plays an important role in regulating mood and socioemotional functioning, and evidence suggests that AVP-D is associated with oxytocin deficiency. We are pleased to support the FOCUS study at MGH, which will evaluate our investigational intranasal potentiated oxytocin products (TNX-1900/TNX-2900) in this population and may help lay the groundwork for future studies of oxytocin replacement therapy."
"The FOCUS study uses a randomized, placebo-controlled crossover design that enables within-patient comparisons of placebo and investigational intranasal potentiated oxytocin product at different doses," said Elizabeth Lawson, M.D., M.M.Sc., principal investigator of the study and Director, Interdisciplinary Oxytocin Research Program in the Neuroendocrine Unit, Department of Medicine at MGH. "This approach will provide critical first data to inform future larger-scale clinical trials for patients with AVP-D. Ultimately, our goal is to generate insights that can lead to better treatments and improved quality of life for patients living with this condition."
The FOCUS study (Feasibility of Oxytocin for Clinical Use and Socioemotional wellbeing) is a randomized, double-blind, placebo-controlled crossover pilot study that will evaluate single-dose investigational intranasal potentiated oxytocin product at two different doses (6 IU, TNX-2900 and 24 IU, TNX-1900) on markers of anxiety, depression, and socioemotional functioning in patients with AVP-D, formerly known as central diabetes insipidus. An exploratory analysis will assess the effects of two weeks of the investigational products replacement on mental health outcomes.
Posted In: TNXP
