SOUTH SAN FRANCISCO, Calif.,
April 28, 2020 /PRNewswire/ --
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 functioning.
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.
"The 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 future."
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 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.
About PH94B
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
SAD. View more background on SAD and PH94B's mechanism of
action.
About Adjustment Disorder
According 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 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
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 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, social anxiety
disorder and other anxiety disorders, including the Company's
expectation that its planned submission to the FDA regarding its
proposed Phase 2 Part A clinical development of PH94B for treatment
of adjustment disorder 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 substantial additional capital to support
our operations, including our ongoing preclinical and clinical
development activities; and (vii) we may encounter technical and
other unexpected hurdles in the manufacturing and development of
PH94B and/or our other 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.
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SOURCE VistaGen Therapeutics