VistaGen Therapeutics Expands Clinical Development of PH94B with Initiation of Phase 2A Trial in Adjustment Disorder

Study Launches Phase 2A Clinical Program Designed to Explore PH94B’s Potential in Multiple Additional Anxiety Disorders

Phase 2A Study in Adjustment Disorder to Run in Parallel with Ongoing Phase 3 Studies in Acute Treatment of Social Anxiety Disorder

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., Oct. 14, 2021 (GLOBE NEWSWIRE) — VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a biopharmaceutical company committed to developing a new generation of medicines with the potential to go beyond the current standard of care for anxiety, depression, and other central nervous system (CNS) disorders, today announced the initiation of a Phase 2A clinical trial to evaluate the efficacy, safety and tolerability of PH94B as a potential treatment of anxiety in adults with Adjustment Disorder with Anxiety (AjDA). In parallel with advancing its ongoing PALISADE Phase 3 clinical program for PH94B in the acute treatment of anxiety in adults with Social Anxiety Disorder (SAD), the Company plans to explore PH94B’s potential in additional anxiety disorders through a series of small Phase 2A trials, the first of which is in AjDA. PH94B is an investigational pherine nasal spray with a unique potential mechanism of action designed to achieve rapid-onset anti-anxiety effects without requiring systemic uptake or causing benzodiazepine-like side effects and safety concerns.

The exploratory Phase 2A clinical trial of PH94B in AjDA is a randomized, double-blind, placebo-controlled study with an enrollment target of approximately 40 adults at clinical sites in the Boston and New York City metro areas. Dr. Michael Liebowitz, a Columbia University psychiatrist, former director and founder of the Anxiety Disorders Clinic at the New York State Psychiatric Institute, and director of the Medical Research Network in New York City is serving as Principal Investigator of the trial. The study’s primary outcome measure is the change from baseline in anxiety level as measured by the Hamilton Anxiety Rating Scale (HAM-A). Additional details about the clinical trial can be found at www.clinicaltrials.gov, identifier NCT04404192.

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