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EX-10.2 - MATERIAL CONTRACTS - VistaGen Therapeutics, Inc. | ex10-2.htm |
EX-10.1 - MATERIAL CONTRACTS - VistaGen Therapeutics, Inc. | ex10-1.htm |
8-K - CURRENT REPORT - VistaGen Therapeutics, Inc. | vtgn8k_sep112018.htm |
Exhibit
99.1
VistaGen Therapeutics Acquires Worldwide License of Phase 3-Ready
CNS Drug Candidate from Pherin Pharmaceuticals for As-Needed
Treatment of Social Anxiety Disorder
●
Phase 3-ready asset expands VistaGen’s CNS pipeline and
complements its neuropsychiatry focus on Major Depressive Disorder
(MDD) with AV-101
●
Novel PH94B nasal spray expected to enter pivotal Phase 3
development for as-needed (PRN) treatment of Social Anxiety
Disorder (SAD) in the first half of 2019; positioned to drive a
paradigm shift towards rapid-acting treatment of SAD, without risk
of addiction
●
Patents on the use of PH94B nasal spray to treat SAD have been
granted in the U.S., Europe, Japan, China, Korea and numerous other
countries
South San Francisco, CA and Mountain View, CA (September 13,
2018) – VistaGen Therapeutics,
Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical
company focused on developing new generation medicines for
depression and other central nervous system (CNS) diseases and
disorders with high unmet need, and Pherin Pharmaceuticals, Inc.,
a biopharmaceutical company
focused on development of novel treatments for neuropsychiatric and
neuroendocrine conditions, today announced the signing
of a license agreement granting VistaGen exclusive worldwide rights
to develop and commercialize PH94B nasal spray, a Phase 3-ready
drug candidate for as-needed (PRN) treatment of Social Anxiety
Disorder (SAD).
“SAD
affects nearly 15 million Americans. Currently, there is no
FDA-approved treatment that provides rapid-acting relief, and
sedatives used off-label carry with them the risk of addiction and
other significant side effects and safety concerns. PH94B clinical
data are compelling and support its potential to be a
first-in-class, rapid-acting, self-administered, PRN treatment
alternative, without sedation, risk of addiction or other safety
concerns, for millions affected by SAD in the U.S. and other major
markets. This transaction not only expands and diversifies our CNS
pipeline to include SAD, but also firmly complements our
patent-protected, neuropsychiatry focus on MDD with AV-101 in our
ongoing Phase 2 ELEVATE Study,” said Shawn Singh, Chief
Executive Officer of VistaGen. “We are excited to be
working with Pherin’s innovative team to develop and
commercialize this medically and socially impactful treatment. Our
key objective for the PH94B program is to commence our initial
pivotal Phase 3 clinical trial of PH94B nasal spray for SAD during
the first half of 2019.”
Pherin’s
first-in-class proprietary compounds called “pherines”
are synthetic neuroactive steroids that engage nasal chemosensory
receptors which, in turn, inhibit nerve circuits mediating
behavioral and physiological effects of anxiety. This mechanism of
action, the rapid onset of efficacy, and the excellent safety and
tolerability profile shown in multiple previous clinical trials,
including a pilot Phase 3 feasibility study for evaluating the
safety and efficacy of PH94B, make PH94B a novel product candidate
for the acute, intermittent and long-term treatment of individuals
with SAD.
Dr.
Louis Monti, Executive Vice President of Pherin, stated,
“This agreement provides a meaningful opportunity to continue
our clinical progress and advance our mission to bring novel
treatment alternatives to the many individuals affected with SAD.
We are confident VistaGen will build upon our earlier clinical
studies, which provided impressive evidence of rapid (10-15
minutes) anxiety reduction for subjects with SAD. In all prior
clinical studies, PH94B was well tolerated and there were no
adverse events associated with nasal spray administration. Our
prior clinical studies support the potential of PH94B to be a
superior treatment alternative for SAD due to the demonstrated
rapid onset of efficacy, route of administration, as-needed dosing
convenience, and excellent safety profile compared to other
existing therapeutic options which require chronic dosing and have
concurrent side effects.”
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An estimated 12.1% of U.S. adults experience SAD at some time in
their lives.1 SAD is characterized by excessive
anxiety about scrutiny or evaluation by others that leads an
individual to avoid social situations and/or
performance.
2 SAD affects social, academic and work
life, and often presents with other anxiety disorders, MDD and
substance use disorders, and the onset of SAD generally precedes
that of other disorders.3 Currently, selective serotonin reuptake
inhibitors (SSRIs) and selective serotonin-norepinephrine reuptake
inhibitors (SNRIs) are FDA-approved for treatment of SAD, but they
take weeks to months to work, must be taken chronically and present
numerous side effects.
VistaGen
has also acquired an option from Pherin to license an additional
CNS neuropsychiatry-focused product in Phase 2 development. In
connection with the consummation of the license and option
agreements, VistaGen issued to Pherin $2.25 million of unregistered
common stock (1,630,435 unregistered shares).
About PH94B
PH94B
was developed from proprietary compounds called pherines.
Administered as a nasal spray, PH94B acts locally on peripheral
nasal chemosensory receptors that trigger rapid activation of the
limbic system areas of the brain associated with SAD. This
mechanism of pharmacological action, the rapid onset of efficacy,
and the excellent safety and tolerability profile shown in clinical
trials make PH94B an excellent product candidate for the acute
intermittent and long-term treatment of individuals with
SAD.
About Social Anxiety Disorder
SAD,
also called social phobia, affects approximately 15 million
American adults and is the third most common psychiatric condition
after depression and substance use.2 SAD is
characterized by a persistent and unreasonable fear of one or more
social or performance situations, where the individual fears that
he or she will act in a way or show symptoms that will be
embarrassing or humiliating, leading to avoidance of the situations
when possible and anxiety or distress when they occur.2 These fears have
a significant impact on the person’s employment, social
activities and overall quality of life. SAD is commonly treated
chronically with antidepressants, which have a slow onset of effect
(several weeks) and known side effects that may make them
unattractive to individuals affected by SAD.
About AV-101
AV-101
is an oral, non-opioid, non-sedating NMDA receptor glycine B
antagonist with potential to be a new at-home treatment for major
depressive disorder and multiple CNS indications with high unmet
need. AV-101 is currently in Phase 2 clinical development in the
United States. ELEVATE
is VistaGen’s ongoing Phase 2 clinical trial designed to
evaluate the efficacy and safety of adjunctive use of oral AV-101
for MDD in individuals with an inadequate response to standard
antidepressant therapy with either an FDA-approved SSRI or SNRI.
The FDA has granted Fast Track
designation to AV-101 for development as a potential
adjunctive treatment of MDD.
About VistaGen
VistaGen
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
developing new generation medicines for depression, SAD and other
CNS diseases and disorders with high unmet need. For more
information, please visit www.vistagen.com
and connect with VistaGen on Twitter,
LinkedIn
and Facebook.
______________________
1 https://www.nimh.nih.gov/health/statistics/social-anxiety-disorder.shtml
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About Pherin
Pherin
Pharmaceuticals, Inc. is a privately held clinical-stage drug
development company that discovered and developed proprietary
molecules, “pherines,” for the acute and intermittent
treatment of neuropsychiatric and neuroendocrine conditions. For
more information please visit www.pherin.com.
Forward-Looking Statements
This
release contains various statements concerning VistaGen's future
expectations, plans and prospects, including without limitation,
our expectations regarding development of our drug candidates,
including AV-101 and PH94B, our intellectual property and
commercial protection of our drug candidates, all of which
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. Among these risks
is the possibility that (i) we may encounter unexpected adverse
events in patients in our clinical development of AV-101 or PH94B
that cause us to discontinue further development of either drug
candidate, (ii) we may not be able to successfully demonstrate the
safety and efficacy of AV-101 or PH94B at each stage of clinical
development, (iii) success in preclinical studies or in early-stage
clinical trials may not be repeated or observed in ongoing or
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 AV-101 and/or 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 AV-101 or PH94B, (vi) we may not have access to or
be able to secure substantial additional capital to support our
operations, including clinical development of AV-101 and/or PH94B
activities described above; and (vii) we may encounter technical
and other unexpected hurdles in the manufacturing and development
of AV-101 or PH94B. 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.
Company Contact
Mark A.
McPartland
VistaGen
Therapeutics Inc.
Phone:
+1 (650) 577-3600
Email: IR@vistagen.com
Louis Monti, MD, PhD
Pherin Pharmaceuticals, Inc.
Email: lmonti@pherin.com
Investor Contact
Valter
Pinto / Allison Soss
KCSA
Strategic Communications
Phone:
+1 (212) 896-1254/+1 (212) 896-1267
Email: VistaGen@KCSA.com
Media Contact
Caitlin
Kasunich / Lisa Lipson
KCSA
Strategic Communications
Phone:
+1 (212) 896-1241/+1 (508) 843-6428
Email: VistaGen@KCSA.com
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