Attached files
file | filename |
---|---|
EX-99.1 - EARNINGS RELEASE - VistaGen Therapeutics, Inc. | ex99-1.htm |
8-K - CURRENT REPORT - VistaGen Therapeutics, Inc. | vtgn8k_nov122020.htm |
Exhibit 99.2
VistaGen Reports Positive Preclinical Data Differentiating
Mechanism of Action of PH94B from Risk-Ridden
Benzodiazepines
New electrophysiological data demonstrate that PH94B does not
directly modulate GABA (gamma aminobutyric acid)
receptors
SOUTH SAN FRANCISCO, Calif., November 12, 2020 – VistaGen
Therapeutics (NASDAQ: VTGN), a
biopharmaceutical company developing new generation medicines for
anxiety, depression and other central nervous system (CNS)
disorders, today announced new in
vitro electrophysiology data
demonstrating that the mechanism of action of PH94B, the intranasal
neuroactive steroid the Company is preparing for Phase 3
development as a potential acute rapid-onset treatment of anxiety
in adults with social anxiety disorder, does not involve direct
activation of GABA-A receptors, in distinct contrast to the
mechanism of action of benzodiazepines (“benzos”),
which act as direct positive modulators of GABA-A
receptors.
“We
are very pleased with the results of these studies that suggest
PH94B’s mechanism of action may not have benzodiazepine-like
side effects, such as sedation and cognitive impairment, or abuse
liability,” stated Shawn K.
Singh, Chief Executive Officer of VistaGen. “While
benzodiazepines provide relief for many Americans struggling with
anxiety, their extremely risky safety profile does not lend itself
to long term use. The mechanism of action contributes to the safety
profile. As we have seen in Phase 2 clinical studies, while PH94B
is able to produce rapid-onset benzo-like, anti-anxiety effects,
this study demonstrates that PH94B does not have a benzo-like
mechanism of action. As we approach Phase 3 development of PH94B,
especially given the FDA’s recent public announcement about
safety concerns associated with benzo use, these new data make us
even more excited about PH94B’s potential to change lives
without the risky side effects and safety concerns of
benzos.”
Recently,
the U.S. Food and Drug Administration (FDA) released a Drug Safety
Communication (DSC) detailing the risks associated with use of
benzodiazepines, a class of drugs commonly prescribed for treatment
of anxiety disorders and other conditions. According to the FDA
communication, 92 million benzodiazepine prescriptions were filled
in 2019. The FDA’s DSC detailed safety concerns regarding the
serious risks of abuse, addiction, physical dependence, and
withdrawal reactions linked to long-term use of benzodiazepines,
and the FDA announced that it is requiring an updated Boxed
Warning, the FDA’s most prominent type of safety warning, for
all benzodiazepine medications.
“We thought it was important to conduct a study to help
differentiate the mechanism of action of PH94B from that of
benzodiazepines, therefore, we contracted with EuroFins Discovery
to determine whether PH94B has positive modulatory effects on GABA
receptors using in
vitro patch clamp
electrophysiology,” noted Mark A. Smith, M.D., Ph.D.,
Chief Medical Officer of VistaGen. “Benzodiazepines
such as alprazolam and diazepam mediate their anti-anxiety effects
by acting as positive modulators at GABA receptors to make them
more responsive to GABA and thereby increase inhibitory neuronal
activity in the brain. PH94B had no agonist or antagonist effects
on GABA receptors. While PH94B may regulate endogenous GABA
circuits in the brain, it does not appear to directly bind to or
modulate GABA receptors at concentrations
<10mM,
which differentiates its mechanism of action from
benzodiazepines.”
These studies are significant because they indicate that PH94B has
no relevant benzodiazepine-like activity. With widespread
anxiety-provoking stressors related to the COVID-19 pandemic, civil
unrest, election results, the economy, and distance learning during
2020, the number of individuals facing anxiety disorders is rising
and a safer treatment alternative to benzodiazepines is imperative.
PH94B may have the potential to displace benzodiazepines and become
the safer alternative in the drug treatment paradigm for anxiety
disorders.
About PH94B
PH94B is an innovative odorless synthetic neuroactive steroid nasal
spray with therapeutic potential in a wide range of mental health
disorders involving anxiety or phobia. Self-administered in
microgram-level doses, PH94B produces rapid onset (within
approximately 15 minutes) anti-anxiety effects and does not require
systemic uptake and distribution to generate these
effects.
VistaGen is currently preparing PH94B for pivotal Phase 3
development as a potential acute treatment of anxiety in adults
with Social Anxiety Disorder (SAD). The FDA has granted Fast Track
designation for development of PH94B for this indication, believed
to be the first such designation by the FDA for a drug candidate
for SAD.
With its
rapid-onset pharmacology, lack of systemic exposure and sedation,
and its excellent safety profile in all studies to date, we believe
PH94B has potential to provide a safe alternative to
benzodiazepines and other pharmacological alternatives in the drug
treatment paradigm for anxiety disorders. View more background
information on SAD and a video on PH94B's mechanism of
action.
About VistaGen
VistaGen Therapeutics is a clinical-stage biopharmaceutical company
developing and commercializing differentiated new generation
medicines that go beyond the current standard of care for anxiety,
depression and other CNS disorders. Each of VistaGen's three drug
candidates has a differentiated mechanism of action, an exceptional
safety profile in all studies to date, and therapeutic potential in
multiple CNS markets. For more information, please visit
www.vistagen.com
and connect with VistaGen on
Twitter,
LinkedIn
and Facebook.
Forward Looking Statements
Various statements in this release are "forward-looking statements"
concerning VistaGen's future expectations, plans and prospects,
including the potential for successful Phase 3 development of
PH94B. These forward-looking statements are neither promises nor
guarantees of future performance, and are subject to a variety of
risks and uncertainties which could cause actual results to differ
materially from those contemplated in these forward-looking
statements, including the risks that: development and approval of
PH94B may not be achieved in any market; the FDA may decide that
the results of the Company's PH94B Phase 3 clinical program are not
sufficient for regulatory approval for acute treatment of anxiety
in adult patients with SAD or any other anxiety-related disorder;
development of PH94B may not be successful in any indication;
success in nonclinical studies or in earlier-stage clinical trials
may not be repeated or observed in future studies which may not
support further development or be sufficient to gain regulatory
approval to market PH94B; adverse events may be encountered at any
stage of development that negatively impact further development.
Other risks and uncertainties include, but are not limited to,
issues related to: adverse healthcare reforms and changes of laws
and regulations; general industry and market conditions;
manufacturing and marketing risks, which may include, but are not
limited to, unavailability of or delays in delivery of raw
materials for manufacture of PH94B; inadequate and/or untimely
supply of PH94B to meet demand; entry of competitive products; and
other technical and unexpected hurdles in the development,
manufacture and commercialization of PH94B, as well as those risks
more fully discussed in the section entitled "Risk Factors" in
VistaGen's most recent Annual Report on Form 10-K for the year
ended March 31, 2020, as well as discussions of potential risks,
uncertainties, and other important factors in either company's
other filings with the Securities and Exchange Commission. In
addition, any forward-looking statements represent the Company's
views only as of today and should not be relied upon as
representing its views as of any subsequent date. The Company
explicitly disclaims any obligation to update any forward-looking
statements.
VistaGen Company Contact
Mark A. McPartland
VistaGen Therapeutics Inc.
Phone: +1 (650) 577-3606
Email: IR@vistagen.com