SOUTH SAN FRANCISCO, Calif.,
Nov. 12, 2020 /PRNewswire/
-- 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.
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SOURCE VistaGen Therapeutics