Full Press Release Details
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
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
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
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
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.
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
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
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.
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).
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
About Social Anxiety Disorder
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