VistaGen’s Poster Presentation at the Anxiety and Depression Association of America’s 2021 Annual Conference Differentiat...
March 22 2021 - 8:30AM
VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a biopharmaceutical
company committed to developing a new generation of medicines with
the potential to go beyond the current standard of care for
anxiety, depression and other central nervous system (CNS)
disorders, announced today that data highlighting the proposed
mechanism of action (MOA) of its Phase 3 investigational drug
candidate, PH94B nasal spray, were recently presented in a poster
session at the Anxiety and Depression Association of America’s 2021
Virtual Annual Conference. PH94B is designed with potential to
provide rapid-onset acute treatment of anxiety for millions of
individuals suffering from social anxiety disorder (SAD) without
directly activating gamma-amino butyric acid (GABA-A) receptors.
PH94B’s MOA is, therefore, fundamentally differentiated from the
MOA of benzodiazepines such as alprazolam, diazepam and lorazepam,
which are direct GABA-A receptor positive modulators. Among
VistaGen’s core goals is for PH94B to displace these and other
widely-used but highly-addictive benzodiazepines in the acute
treatment paradigm for SAD and other anxiety disorders and phobias.
PH94B is an investigational odorless pherine
nasal spray entering Phase 3 clinical development in the U.S. for
the acute treatment of anxiety in adults with SAD, the third most
common mental health disorder among Americans, affecting
approximately 20 million individuals. PH94B also has therapeutic
potential in a wide range of additional anxiety disorders and
phobias. Self-administered in microgram-level doses, in Phase 2
clinical studies, PH94B produced rapid-onset anti-anxiety effects
within approximately 15 minutes, without the troubling side effects
associated with benzodiazepines.
To help differentiate PH94B’s mechanism of
action from that of benzodiazepines, VistaGen studied whether PH94B
had positive modulatory effects on GABA receptors.
Key results in the recent ADAA poster
presentation include the following:
- PH94B had no significant effect on
GABA potentiation at doses up to 10 micromolar, compared to the 300
percent potentiation induced by diazepam, a commonly-prescribed
benzodiazepine.
- The concentration of PH94B that
gives the half-maximal response (EC50) could not be calculated for
PH94B, whereas diazepam’s half-maximal response (EC50) was 72
nanomolar.
- PH94B had no agonist or antagonist
effects on GABA receptors compared to the effect of GABA (EC50= 4.7
micromolar) and bicuculline (EC50= 1.6 micromolar),
respectively.
“The results are in agreement with PH94B’s lack
of benzodiazepine-like side effects and safety concerns reported in
PH94B clinical studies – for example, lack of sedation, cognitive
impairment or abuse liability potential,” said Louis Monti, M.D.,
Ph.D., Vice President, Translational Medicine of VistaGen. “This
study demonstrated that PH94B’s mechanism of action is through
neural regulation of forward inhibitory GABAergic neurons in the
limbic amygdala and is differentiated from benzodiazepines’
mechanism of action, which is through a direct local potentiating
effect on GABA receptors. These data are key in understanding
PH94B’s overall potential effectiveness and safety for individuals
suffering from SAD and many other anxiety disorders.”
“Given the FDA’s recent Drug Safety
Communication that outlined and highlighted the safety risks
associated with benzodiazepine use, the implications resulting from
this study are significant,” added Mark Smith, M.D., Ph.D., Chief
Medical Officer of VistaGen. “PH94B may have the potential to
displace benzodiazepines altogether and become the safer
alternative to help the millions of Americans suffering from
anxiety with limited options for safe, effective treatment options.
These existing treatments can actually hurt instead of help. We
look forward to launching our Phase 3 clinical development program
for PH94B next quarter and continuing to push forward in our
mission to get it into the hands of those in need as soon as
possible.”
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.
About PH94B PH94B is an
innovative odorless investigational pherine nasal spray with
therapeutic potential in multiple mental health disorders involving
anxiety or phobia and is designed to have a rapid-onset therapeutic
effect. During Phase 2 clinical studies for the potential acute
treatment of social anxiety disorder (SAD), PH94B was
self-administered in microgram-level doses and produced rapid-onset
(within approximately 15 minutes) anti-anxiety effects without
sedation or systemic uptake and distribution.
VistaGen is currently preparing PH94B for Phase
3 development as a potential acute treatment of anxiety in adults
with SAD. The FDA has granted Fast Track designation for the
development of PH94B for this indication.
With rapid-onset pharmacology and favorable
safety results seen in all clinical studies to date, VistaGen
believes PH94B has the potential to provide an innovative treatment
alternative to benzodiazepines and other pharmaceuticals in the
acute treatment paradigm for SAD and other anxiety disorders.
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
for SAD. 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, and in our most recent Quarterly Report on
Form 10-Q for the quarter and nine months ended December 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
McPartland VistaGen Therapeutics Phone: (650) 577-3606 Email:
IR@vistagen.com
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