VistaGen Therapeutics Reports New Preclinical Mechanism of Action Data Supporting PH94B’s Potential Anti-Anxiety Activity via Peripheral Nasal Neurons without Entry into the Brain
October 05 2021 - 8:00AM
VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical company
developing a new generation of medicines with potential to go
beyond the current standard of care for anxiety, depression and
other central nervous system (CNS) disorders, today announced new
mechanism of action data from a preclinical tissue distribution
study in laboratory rats demonstrating that a single intranasal
administration of radiolabeled carbon-14 PH94B ([14C]PH94B) was
largely confined to the nasal passages and minimal or undetectable
in most other tissues, including the CNS. No appreciable activity
was observed in the brain.
These data further support the proposed
mechanism of action of PH94B involving binding to receptors of
peripheral neurons in the nasal passages, not to neuronal receptors
in the CNS, and thereby limiting transport of molecules to the
circulatory system and minimizing potential systemic exposure.
"We are very excited about these new study
results, which further highlight how the mechanism of action of
PH94B is fundamentally differentiated from all current anti-anxiety
therapies," stated Shawn K. Singh, Chief Executive Officer of
VistaGen. "When combined with previously announced preclinical
electrophysiology data demonstrating that the mechanism of action
of PH94B does not involve direct activation of GABA-A receptors,
which is in distinct contrast to the mechanism of action of
benzodiazepines, we see a growing body of evidence suggesting that
PH94B has potential to achieve anti-anxiety effects without
requiring systemic uptake or causing benzodiazepine-like side
effects and safety concerns. At a time when the current drug
treatment paradigm for Social Anxiety Disorder, or SAD, is falling
far short of delivering necessary relief without worrisome
potential consequences, an innovative treatment alternative is
imperative. If successfully developed in our ongoing PALISADE Phase
3 Program, PH94B has the potential to fill that void as the first
fast-acting, on demand acute treatment of anxiety for more than 23
million Americans who suffer from SAD."
"In this study, the absence of radiolabeled
PH94B in the rodent brain is an encouraging sign that PH94B may
have limited circulatory systemic exposure when administered
intranasally," stated Mark Smith, MD, PhD, Chief Medical Officer of
VistaGen. "Furthermore, the tissue distribution of radiolabeled
carbon-14 PH94B was minimal in the tested lab animals, with the
highest concentration primarily in the nasal turbnates. These
findings strongly support a local disposition of PH94B in the
olfactory receptor neurons and an absence of binding of PH94B in
the central nervous system. We believe that this is another
positive indication supporting the clinical development of
PH94B."
About PH94BPH94B is an investigational,
first-in-class, odorless, rapid-onset (approximately 15 minutes)
CNS pherine nasal spray with the potential to be the first
FDA-approved, fast-acting, on-demand acute treatment of anxiety for
millions of Americans who suffer from Social Anxiety Disorder
(SAD), with therapeutic potential in multiple additional anxiety
disorders. Administered intranasally at microgram doses, PH94B
activates peripheral nasal chemosensory neurons that trigger neural
circuits in the brain that suppress fear and anxiety. Following
successful Phase 2 development, VistaGen has initiated two ongoing
Phase 3 clinical trials of PH94B in its PALISADE Phase 3 Program,
PALISADE-1 and PALISADE-2, for potential acute treatment of anxiety
in adults with SAD. The FDA has granted Fast Track designation for
the development of PH94B as a treatment for SAD. View more
background on PH94B's unique mechanism of action.
About VistaGen Therapeutics VistaGen
Therapeutics is a biopharmaceutical company committed to developing
and commercializing innovative medicines with potential to go
beyond the current standard of care for anxiety, depression and
other CNS disorders. Each of VistaGen's drug candidates has a
differentiated potential mechanism of action, has been observed to
be well-tolerated in all clinical studies to date and has
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 StatementsVarious 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 the acute treatment
of anxiety in adults with 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:
preclinical study results in laboratory rats and/or other
laboratory animals may not be indicative of potential results in
human clinical trials, including clinical studies in the Company’s
PALISADE Phase 3 Program for PH94B in SAD; success in preclinical
studies or in earlier-stage clinical trials may not be repeated or
observed at any time during the PALISADE Phase 3 Program, including
during PALISADE-1 or PALISADE-2, or future trials, which trials 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;
completion of clinical studies in the Company’s PALISADE Phase 3
Program, including, but not limited to PALISADE-1 and/or
PALISADE-2, may be delayed due to a variety of factors, including
factors related to the ongoing COVID-19 pandemic; development and
approval of PH94B may not be achieved in any market; the FDA may
decide that the results of PALISADE-1 and PALISADE-2 and other
studies in the Company's PALISADE Phase 3 Program for PH94B are not
sufficient to support a U.S. New Drug Application, or for
regulatory approval for the acute treatment of anxiety in adults
with SAD or any other anxiety-related disorder; development of
PH94B may not be successful in any indication. 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 the 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 the
Company's most recent Annual Report on Form 10-K for the year ended
March 31, 2021, and in its most recent Quarterly Report on Form
10-Q for the quarter ended June 30, 2021, as well as discussions of
potential risks, uncertainties, and other important factors in its
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 Contacts Media:Mark McPartland
Vice President, Corporate DevelopmentPhone: (650) 577-3606Email:
markmcp@vistagen.com
Investors:Mark Flather Vice President, Investor RelationsPhone:
(650) 577-3617Email: mflather@vistagen.com
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