Benzinga | Oct 14, 2021 08:07AM EDT

VistaGen Therapeutics Expands Clinical Development Of PH94B With Initiation Of Phase 2A Trial In Adjustment Disorder

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.

"As we continue to advance ongoing Phase 3 clinical development of PH94B in our PALISADE Phase 3 Program in Social Anxiety Disorder, we are excited to launch our Phase 2A clinical program to explore PH94B's potential in multiple additional anxiety disorders with unmet need," said Shawn Singh, Chief Executive Officer of VistaGen. "There has been a significant shift in mental health since early last year. Emotional stress and impaired functioning as a result of anxiety-provoking stressors brought on by sudden changes in health, safety, economic and social circumstances, including the diverse impacts of the COVID-19 pandemic, have directly or indirectly affected hundreds of millions of individuals around the world and may have led to a considerable increase in the prevalence of Adjustment Disorder with Anxiety. We believe the impact of the pandemic on mental health will be long-term and varied across a wide range of anxiety disorders, and we are committed to becoming part of the solution for people who need to find help. Expanding on our ongoing efforts to address the alarming prevalence of Social Anxiety Disorder, the initiation of this exploratory Phase 2A study in Adjustment Disorder with Anxiety is an exciting next step toward our goal."