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Vistagen Announces Completion of Last Patient, Last Visit in Phase 2 Clinical Trial of PH94B for the Treatment of Adjustment Disorder with Anxiety
Topline results of the exploratory Phase 2 clinical study anticipated in Q1 2023 SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Vistagen (Nasdaq: VTGN), a
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"\nTopline results of the exploratory Phase 2 clinical study anticipated in Q1 2023\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nVistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, today announced that the last patient has completed the study protocol in its Phase 2 clinical trial of PH94B for the treatment of adults experiencing adjustment disorder with anxiety (AjDA).\n\nThe exploratory Phase 2 clinical trial is a U.S. multi-center, randomized, double-blind, placebo-controlled study intended to evaluate efficacy, safety and tolerability of PH94B administered four times per day over four weeks for the treatment adjustment disorder with anxiety symptoms in adults. The primary endpoint is the change from baseline in anxiety level as measured by the Hamilton Anxiety Rating Scale (HAM-A) at the end of Week 4 of treatment with PH94B or placebo. Dr. Michael Liebowitz, a former Columbia University psychiatrist, founder of the Anxiety Disorders Clinic at the New York State Psychiatric Institute, and currently director of the Medical Research Network in New York City, is serving as Principal Investigator of the trial. Topline results are anticipated at the end of Q1 2023.\n\n“The four-week treatment protocol for our final enrolled patient is complete. This is a major milestone for our team,” stated Shawn Singh, Chief Executive Officer of Vistagen. “Along with many other mental health challenges, the prevalence of adjustment disorder is alarming due to increasing levels of health, safety, economic and social stressors that adversely impact mental health and wellbeing. Vistagen is dedicated to developing treatments to address the escalating mental health crisis. We look forward to completing data analysis for this important study over the coming months.”\n\nAbout PH94B\n\nVistagen’s PH94B is a first-in-class, rapid-onset investigational pherine nasal spray with a novel proposed mechanism of action (MOA) that regulates the olfactory-amygdala neural circuits of fear and anxiety and attenuates the tone of the sympathetic autonomic nervous system, without systemic distribution, potentiation of GABA-A or direct activity on CNS neurons in the brain. Vistagen is developing PH94B...