VistaGen Therapeutics Inc. (NASDAQ: VTGN) has announced the commencement of phase 2A clinical study to assess safety, tolerability, and efficacy of PH94B as a possible anxiety treatment in people with Adjustment Disorder with Anxiety.
Phase 2A occurring concurrently with Phase 3 PALISADE study
Parallel to its ongoing PALISADE third phase clinical study for PH94B in the acute anxiety treatment in adults with Social Anxiety Disorder (SAD), VistaGen plans to conduct a series of small Phase 2A studies. The first in the series is in AjDA, to investigate PH94B’s potential in other anxiety disorders. PH94B is an experimental phrine nasal spray with a novel possible action mechanism that aims to provide quick-onset anti-anxiety impact without the need for systemic uptake or to create benzodiazepine-like side effects or safety issues.
The PH94B in AjDA exploratory Phase 2A clinical trial is a double-blind, randomized, placebo-controlled study with a goal enrolment of about 40 adults at clinical centers in the New York City and Boston metro areas. As measured by the Hamilton Anxiety Rating Scale, the change in anxiety level from baseline is the study’s major outcome measure.
VistaGen expanding studies to address SAD with AjDA study
CEO Shawn Singh said, “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. There has been a significant shift in mental health since early last year. 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.”