Full Press Release Details
VistaGen Expands PH94B Clinical Development to Include Adjustment
Disorder Related to COVID-19
Proposed Phase 2 Study to Take Place in New York City Under U.S.
Coronavirus Treatment Acceleration Program
SOUTH SAN FRANCISCO, Calif., April 28, 2020 VistaGen
Therapeutics (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
anxiety, depression and other central nervous system (CNS) diseases
and disorders with high unmet medical need, today announced plans
to expand clinical development of PH94B, its first-in-class
rapid-onset neuroactive nasal spray, to include treatment of
adjustment disorder due to stressors related to the COVID-19
pandemic. Adjustment disorder is an emotional or behavioral
reaction considered excessive or out of proportion to a stressful
event or major life change, occurring within three months of the
stressor, and/or significantly impairing a person's social,
occupational and/or other important areas of
VistaGen plans to submit its proposed protocol for a Phase 2 study
of PH94B for treatment of adjustment disorder to the U.S. Food and
Drug Administration (FDA) through the FDA's new Coronavirus
Treatment Acceleration Program (CTAP). The proposed Phase 2 Part A
study will be conducted in New York City, the epicenter of the
COVID-19 pandemic in the U.S., on an open-label basis and involve
approximately 30 subjects suffering from adjustment disorder from
stressors related to the pandemic. Based on the results of the
Phase 2 Part A study, VistaGen plans to advance development to a
Phase 2 Part B randomized, double-blind, placebo-controlled study
of approximately 150 subjects. The FDA previously designated PH94B
for Fast Track development for treatment of social anxiety disorder
(SAD), the first such designation by the FDA for a drug candidate
for SAD. VistaGen is currently preparing for Phase 3 development of
PH94B for treatment of SAD.
Dr. Michael Liebowitz, a member of VistaGen's CNS Clinical
and Regulatory Advisory Board, will serve as Principal Investigator
of the Phase 2 Part A study of PH94B for treatment of adjustment
disorder. Dr. Liebowitz is a Professor of Clinical Psychiatry at
Columbia University and directs the Medical Research Network LLC in
New York City. He directed the Anxiety Disorders Clinic at the New
York State Psychiatric Institute from 1982 to 2006 and is also
creator of the Liebowitz Social Anxiety Scale, or LSAS, a widely
used primary outcome measure in clinical research on SAD, as well
as for evaluation in clinical practice.
COVID-19 pandemic has created fear, anxiety and uncertainty about
our health and the economy that have caused mental health
challenges worldwide, said
Shawn Singh, Chief Executive Officer of VistaGen. After
the immediate medical threats associated with COVID-19 pass, the
pandemic is expected to have a lasting impact on millions of
people. With increases in anxiety-related disorders to be expected,
the need for new, fast-acting and safe treatment alternatives is
greater now than ever before. With its exceptional safety profile
and positive data from Phase 2 development for treatment of social
anxiety disorder, PH94B has significant potential to make a
meaningful difference across the treatment landscape for multiple
anxiety-related disorders.
Mental health-related disorders have escalated and continue
to be overwhelmingly underserved indications as a result of the
current crisis, concluded
Dr. Liebowitz. Today, more
than ever, I am concerned over the suffering of those who are
experiencing debilitating, heightened symptoms of adjustment
disorder and anxiety as a result of the COVID-19 pandemic
and how those individuals are coping and receiving treatment. The
alternatives in the market, both prescribed and not prescribed,
have significant limitations in efficacy and problematic side
effects. We need better alternative treatments as we approach a
vastly different social environment in the near
Therapeutics is a multi-asset, clinical-stage biopharmaceutical
company developing new generation medicines for anxiety, depression
and certain CNS diseases and disorders where current treatments are
inadequate, resulting in high unmet need.
VistaGen's pipeline is
focused on clinical-stage CNS drug candidates with a differentiated
mechanism of action, an exceptional safety profile, and therapeutic
potential in multiple large and growing CNS markets. For more
information, please visit www.vistagen.com
and connect with VistaGen on Twitter, LinkedIn and Facebook.
PH94B is a first-in-class, odorless, rapid-onset
(approximately 10 to 15 minutes) CNS neuroactive nasal spray with
the potential to be the first FDA-approved, fast-acting, on-demand
treatment for millions of Americans who suffer from social anxiety
disorder (SAD), with additional potential in adjustment disorder,
peripartum anxiety, pre/postoperative anxiety or anxiety related to
certain testing such as an MRI, post-traumatic stress disorder,
panic disorder and generalized anxiety disorder. Administered at
microgram doses, PH94B activates nasal chemosensory receptors that
trigger neural circuits in the brain that suppress fear and
anxiety. Following successful Phase 2 development, VistaGen is
preparing for Phase 3 clinical development of PH94B for SAD and
Phase 2 development for adjustment disorder. The FDA has granted
Fast Track designation for development of PH94B as a treatment for
more background on SAD and PH94B's mechanism of
About Adjustment Disorder
to the DSM-5, published by the American Psychiatric Association,
adjustment disorder is the development of emotional or behavioral
symptoms in response to an identifiable stressor(s) occurring
within 3 months of the onset of the stressor(s). These symptoms or
behaviors are clinically significant, as evidenced by one or both
distress that is out of proportion to the severity or intensity of
the stressor, considering the external context and the cultural