SOUTH SAN FRANCISCO, Calif.,
May 18, 2020 /PRNewswire/
-- 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
stressors."
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
Investigator.
About VistaGen
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.
About PH94B
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 of
action.
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
disorder.
About the U.S. FDA Coronavirus Treatment Acceleration Program
(CTAP)
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 effectiveness.
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 submission to the FDA regarding its proposed Phase 2A
clinical study protocol for PH94B for treatment of AjDA
related to the COVID-19 pandemic will qualify for expedited review
under the FDA's CTAP. In addition, statements concerning the
Company's future expectations may include statements regarding
intellectual property and commercial protection of our drug
candidates. Each of these statements constitute forward-looking
statements for the purposes of the safe harbor provisions under the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements are neither promises nor guarantees of
future performance and are subject to a variety of risks and
uncertainties, many of which are beyond our control, and may cause
actual results to differ materially from those contemplated in
these forward-looking statements. Those risks include the
following: (i) we may encounter unexpected adverse events in
patients during our clinical development of any product candidate
that cause us to discontinue further development; (ii) we may not
be able to successfully demonstrate the safety and efficacy of our
product candidates at each stage of clinical development; (iii)
success in preclinical studies or in early-stage clinical trials
may not be repeated or observed future studies, and ongoing or
future preclinical and clinical results may not support further
development of, or be sufficient to gain regulatory approval to
market PH94B; (iv) decisions or actions of regulatory agencies may
negatively affect the progress of, and our ability to proceed with,
further clinical studies or to obtain marketing approval for our
drug candidates; (v) we may not be able to obtain or maintain
adequate intellectual property protection and other forms of
marketing and data exclusivity for our product candidates; (vi) we
may not have access to or be able to secure the substantial
additional capital necessary to support our operations, including
our ongoing and/or planned preclinical and/or clinical development
studies; and (vii) we may encounter technical and other unexpected
hurdles and delays in the manufacturing and development of any of
our product candidates. Certain other risks are more fully
discussed in the section entitled "Risk Factors" in our most recent
annual report on Form 10-K, and subsequent quarterly reports on
Form 10-Q, as well as discussions of potential risks,
uncertainties, and other important factors in our other filings
with the Securities and Exchange Commission (SEC). Our SEC filings
are available on the SEC's website at www.sec.gov. In
addition, any forward-looking statements represent our views only
as of the issuance of this release and should not be relied upon as
representing our views as of any subsequent date. We explicitly
disclaim any obligation to update any forward-looking
statements.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/vistagen-submits-ph94b-phase-2a-study-protocol-for-treatment-of-adjustment-disorder-with-anxiety-related-to-the-covid-19-pandemic-through-us-fdas-coronavirus-treatment-acceleration-program-ctap-301060722.html
SOURCE VistaGen Therapeutics