Full Press Release Details
VistaGen Submits PH94B Phase 2A Study Protocol for Treatment of
Adjustment Disorder with Anxiety Related to the COVID-19 Pandemic
through U.S. FDA's Coronavirus Treatment Acceleration Program
The Proposed Phase 2A Open-label Study will be Conducted in New
SOUTH SAN FRANCISCO, Calif., May 18, 2020 VistaGen
Therapeutics (NASDAQ: VTGN), a
clinical-stage biopharmaceutical company developing new generation
medicines for anxiety and depression, as well as certain central
nervous system (CNS) diseases and disorders with high unmet medical
need, today announced that the Company has submitted its
proposed protocol for a Phase
2A study of PH94B, its investigational anti-anxiety drug, for
treatment of adjustment disorder with anxiety related to the
COVID-19 pandemic to the U.S. Food and Drug Administration (FDA)
through the FDA's new Coronavirus Treatment Acceleration Program
(CTAP). Adjustment disorder is an emotional or behavioral reaction
considered excessive or disproportionate 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 functioning.
The recent onset of mental health stressors associated with
the COVID-19 pandemic is unprecedented and has affected nearly
every person around the world, said Shawn Singh, Chief
Executive Officer of VistaGen. We strongly believe in
PH94B's potential as a first-in-class, rapid-onset
anti-anxiety drug, without systemic exposure or safety concerns of
current anti-anxiety drugs. With successful Phase 2 development of
PH94B for social anxiety disorder completed and preparations for
Phase 3 development underway, we now look forward to Phase 2
development of PH94B for adjustment order, with the goal of
achieving similarly positive treatment outcomes for individuals
struggling to cope with difficulties related to COVID-19, as well
as a wide range of other anxiety-provoking mental health
The proposed Phase 2A 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 patients suffering from
adjustment disorder with anxiety from stressors related to the
pandemic. Dr. Michael Liebowitz, a member of VistaGen's CNS
Clinical and Regulatory Advisory Board, Professor of Clinical Psychiatry at
Columbia University and director of the Medical Research Network in
New York City, will serve as Principal
VistaGen 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 three clinical-stage CNS drug candidates, each 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 therapeutic
potential across a broad range of anxiety-related disorders,
including social anxiety disorder (SAD), adjustment disorder with
anxiety (AjDA), peripartum anxiety, pre/postoperative or testing
(e.g., MRI) anxiety, post-traumatic stress disorder, panic disorder
and generalized anxiety disorder. Self-administered as a nasal
spray at microgram doses, PH94B activates chemosensory receptors in
the nasal passage 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 2A development for AjDA associated with
the COVID-19 pandemic. The FDA has granted Fast Track designation
for development of PH94B as a treatment for SAD, the first such
designation by the FDA for SAD.
View more background on SAD and a video on PH94B's mechanism
About Adjustment Disorder with Anxiety
According to the Diagnostic and Statistical Manual of Mental
Disorders, Fifth Edition (DSM-5), adjustment disorder is the
development of emotional or behavioral symptoms in response to an
identifiable stressor occurring within 3 months of the onset of the
stressor. These symptoms or behaviors are clinically significant,
as evidenced by one or both of the following: marked distress that
is out of proportion to the severity or intensity of the stressor,
considering the external context and the cultural factors that
might influence symptom severity and presentation; or significant
impairment in social, occupational, or other important areas of
functioning. The stress-related disturbance does not represent
normal bereavement or meet the criteria for another mental disorder
and is not merely an exacerbation of a preexisting mental
About the U.S. FDA Coronavirus Treatment Acceleration Program
FDA has created a special emergency program for possible therapies
called the Coronavirus Treatment Acceleration Program (CTAP). The
FDA's CTAP uses every available method to move new treatments
to patients as quickly as possible, while at the same time finding
out whether they are helpful or harmful. The FDA continues to
support clinical trials that are testing new treatments for
COVID-19 so that it gains valuable knowledge about their safety and
To learn more about Coronavirus Treatment Acceleration Program
(CTAP), please use the following link: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap
Forward-Looking Statements
This release contains various statements concerning VistaGen's
future expectations, plans and prospects, including without
limitation, our expectations regarding development and
commercialization of PH94B for adjustment disorder with anxiety
(AjDA), social anxiety disorder and other anxiety-related
disorders, including the Company's expectation that its