Exhibit 99.1
Exhibit 99.1
Positive Pilot Phase 3 Data Position VistaGen’s PH94B
Neuroactive Nasal Spray for Pivotal
Phase 3 Development as a Novel, As-Needed Treatment for
Social Anxiety Disorder
PH94B has potential to be the First FDA-Approved PRN Treatment for
Social Anxiety Disorder
New Findings Presented at the 2019 Anxiety and Depression
Association of America Annual Conference
SOUTH SAN FRANCISCO, CA – April 1, 2019 –
VistaGen
Therapeutics (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
depression, social anxiety disorder and other central nervous
system (CNS) diseases and disorders with high unmet need, announced
today additional results from a positive pilot Phase 3 study of
PH94B, a potential
first-in-class neuroactive nasal spray shown to be effective on an as-needed
(PRN) basis for treatment of social anxiety disorder (SAD).
The new data were presented in a poster session at the 2019 Anxiety and
Depression Association of America (ADAA) Annual Conference
in
Chicago.
In the
22-patient, four-week, randomized, double blind, placebo-controlled
pilot Phase 3 crossover study, subjects receiving PH94B had a
significantly greater decrease in average peak Subjective Units of
Distress scores compared to placebo within one week of
treatment.1 There was also a
significantly greater decrease in Liebowitz Social Anxiety Scale
(LSAS) avoidance scores for subjects who received PH94B first,
before crossing over to placebo. Administered at microgram doses
and consistent with results from prior Phase 2 studies,
PH94B’s safety profile was excellent, with no serious adverse
events. VistaGen is
currently preparing for pivotal Phase 3 development of PH94B as a
novel first-line PRN treatment for SAD, with Dr. Michael Liebowitz,
developer of the LSAS, a widely-used primary outcome measure in SAD
for both clinical research and for evaluation in clinical practice,
acting as Principal Investigator for the study.
“Social anxiety disorder is one of the most prevalent mental
health conditions in the U.S., affecting as many as 15 million
Americans. In both Phase 2 and pilot Phase 3 clinical studies,
PH94B was more effective than placebo in the whole sample on the
primary outcome measure. In the Phase 2 trial, which included both
a public speaking and a social situation challenge, PH94B
significantly improved the primary efficacy endpoint within 10 to
15 minutes of self-administration. These positive results
demonstrate PH94B’s potential to change the lives of millions
of people suffering from SAD,” said Dr. Liebowitz, Principal
Investigator of the pilot Phase 3 study. “I support
VistaGen’s plans for a pivotal Phase 3 program launch in
2020. PH94B neuroactive nasal spray has potential to be the first
FDA-approved PRN treatment for SAD.”
“Current treatments for SAD fall far short of patient
needs,” stated Mark Smith, MD, PhD, VistaGen’s Chief
Medical Officer. “With its unique mechanism of action,
exceptional safety profile and rapid-onset activity, we are excited
about PH94B’s potential to transform the current treatment
paradigm for SAD. We look forward to working closely with the FDA
and Dr. Liebowitz as we prepare for and execute pivotal Phase 3
development of PH94B for SAD.”
About PH94B Neuroactive Nasal Spray
PH94B
neuroactive nasal spray is fundamentally different from all current
treatments for SAD. Developed from proprietary compounds called
pherines and administered as a nasal spray, PH94B activates nasal
chemosensory receptors that trigger neural circuits in the brain
that suppress fear and anxiety. Its novel mechanism of
pharmacological action, rapid-onset of therapeutic effects and
exceptional safety and tolerability profile shown in clinical
trials to date make PH94B neuroactive nasal spray an excellent
product candidate with potential to become the first FDA-approved
PRN treatment for SAD.
In a
published double-blind, placebo-controlled Phase 2 clinical trial,
PH94B neuroactive nasal spray was significantly more effective than
placebo in reducing public-speaking and social interaction anxiety
on laboratory challenges of individuals with SAD.2.
About Social Anxiety Disorder
SAD
affects as many as 15 million Americans and is the third most
common psychiatric condition after depression and substance use.
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.
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 VistaGen
VistaGen
Therapeutics is a clinical-stage biopharmaceutical company
developing new generation medicines for multiple CNS diseases and
disorders with high unmet need. VistaGen’s CNS pipeline
includes three drug candidates (AV-101, PH10, and PH94B) with
potential for at-home use, rapid-onset therapeutic benefits and
exceptional safety. Each CNS drug candidate in VistaGen's pipeline
is either currently in or has completed Phase 2 clinical
development. AV-101, an oral NMDA receptor glycine site antagonist
(a full antagonist), is in Phase 2 development in the U.S. for
major depressive disorder (MDD) and in a first-step target
engagement study in healthy volunteer U.S. military Veterans for
suicidal ideation. The FDA has granted Fast Track designation for
development of AV-101, both as a potential adjunctive treatment
for MDD and as a non-opioid treatment
for neuropathic pain. PH10 is a potential first-in-class
neuroactive nasal spray with rapid-onset antidepressant effects
observed at microgram doses and without systemic exposure. PH10 is
in Phase 2 development for MDD. PH94B is a potential first-in-class
neuroactive nasal spray with rapid-onset effects observed at
microgram doses and without systemic exposure. Phase 2 and pilot
Phase 3 development of PH94B for SAD has been completed
successfully, and PH94B is now being prepared for pivotal Phase 3
development as an on-demand PRN treatment for SAD.
For
more information, please visit www.vistagen.com
and connect with VistaGen on Twitter,
LinkedIn and
Facebook.
1 Liebowitz MR, Hanover
R, Draine A, Lemming R, Careri J, Monti L (2016). Effect of
as‐needed
use of intranasal PH94B on social and performance anxiety in
individuals with social anxiety disorder. Depress
Anxiety 33: 1081-1089.
2
Liebowitz,
MR, Salman, E, Nicolini, H, Rosenthal, N, Hanover, R, Monti. L
(2014). Effect of an acute intranasal aerosol dose of PH94B on
social and performance anxiety in women with social anxiety
disorder. Am. J.
Psychiatry 171:675-682.
Forward-Looking Statements
This
release contains various statements concerning VistaGen's future
expectations, plans and prospects, including without limitation,
our expectations regarding development and commercialization of our
drug candidates, including AV-101 for MDD, neuropathic pain and
suicidal ideation, PH94B for SAD, and PH10 for MDD, 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 during our clinical development of any product
candidate that cause us to discontinue further development, (ii) we
may not be able to successfully demonstrate the safety and efficacy
of our product candidates 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, PH94B, and/or PH10, (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 our product candidates, (vi) we may not have access
to or be able to secure substantial additional capital to support
our operations, including our ongoing clinical development
activities, and (vii) we may encounter technical and other
unexpected hurdles in the manufacturing and development of any of
our product candidates. 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
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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