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.”
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.
About PherinPherin 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 StatementsThis 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 ContactMark A. McPartland VistaGen
Therapeutics Inc. Phone: +1 (650) 577-3600
Email: IR@vistagen.com
Louis Monti, MD, PhDPherin Pharmaceuticals, Inc.Email:
lmonti@pherin.com
Investor ContactValter Pinto / Allison Soss
KCSA Strategic Communications Phone: +1 (212) 896-1254/+1 (212)
896-1267 Email: VistaGen@KCSA.com
Media ContactCaitlin Kasunich / Lisa Lipson
KCSA Strategic Communications Phone: +1 (212) 896-1241/+1 (508)
843-6428 Email: VistaGen@KCSA.com
________________________
1
https://www.nimh.nih.gov/health/statistics/social-anxiety-disorder.shtml2
https://adaa.org/understanding-anxiety/social-anxiety-disorder3
American Psychiatric Association. (2013). Diagnostic and
statistical manual of mental disorders (5th ed.). Arlington, VA:
American Psychiatric Publishing.
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