Exhibit 99.1
VistaGen Announces Positive Results of Newly Published Exploratory
Phase 2a Study of PH10 for Rapid-Onset Treatment of Major
Depressive Disorder
PH10, a Neurosteroid Nasal Spray, Demonstrated Significant
Rapid-Onset Antidepressive Benefit versus Placebo, without
Psychological Side Effects or Safety Concerns Often Associated with
Ketamine-based Therapy
SOUTH SAN FRANCISCO, Calif., February 20, 2020 – VistaGen
Therapeutics (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
central nervous system (CNS) diseases and disorders with high unmet
medical need, today announced positive
results from a newly published exploratory Phase 2a clinical study
of PH10, its investigational first-in-class, rapid-onset synthetic
neurosteroid nasal spray, for treatment of major depressive
disorder (MDD). Results of the double-blind, randomized,
placebo-controlled Phase 2a study have been published in the
peer-reviewed
British Journal of Pharmaceutical and Medical
Research.
In the single-site exploratory Phase 2a study (n=30), randomized
participants received placebo or either a 3.2
µg or a 6.4
µg dose of PH10
neuroactive nasal spray twice daily for eight weeks. Change in
total score on the 17-item Hamilton Depression Rating Scale
(HAM-D-17), a multiple-item questionnaire used to provide an
indication of depression as a guide to evaluate recovery, was
measured at the end of each week of treatment. A rapid
antidepressant benefit from the PH10 6.4
µg dose was evidenced by
changes in HAM-D-17 scores at the end of the first week of
treatment. After one week of treatment, the mean reduction of
HAM-D-17 scores for the PH10 6.4
µg group was 10.1
points, which was statistically greater (p = 0.03) than the mean
reduction in the placebo group of 4.2 points from baseline. Also,
at the end of the last week of treatment (Week 8), the PH10
6.4
µg group showed a mean
HAM-D-17 score reduction of 17.8, which was statistically greater
than the mean reduction in the placebo group of 10.9 points from
baseline (p = 0.02). Thus, in the PH10 6.4
µg treatment group, the
HAM-D-17 score improved significantly from the baseline within one
week and this effect was sustained until the Week 8 study endpoint.
Notably, both the PH10 3.2
µg and 6.4
µg treatment groups
showed strong effect sizes after one week of treatment (0.72 for
the 3.2
µg dose and 1.01 for the
6.4
µg dose) and at the Week
8 study endpoint (0.74 for the 3.2
µg dose and 0.95 for the
6.4
µg
dose).
There were no reports of serious adverse events. At the end of
treatment, all subjects reported to have tolerated twice daily
self-administration. The results of this peer-reviewed published
study suggest PH10’s potential as a non-systemic,
rapid-onset, new generation antidepressant for the millions of
people suffering from depression around the world. VistaGen is
currently preparing for Phase 2b clinical development of PH10 in
the U.S. for treatment of MDD.
“The results of this exploratory Phase 2a clinical study
demonstrate PH10’s exciting potential to treat patients with
MDD with a first-in-class, non-systemic, rapid-onset antidepressant
without the serious psychological side effects and safety concerns
of ketamine-based therapy. The large separation from placebo seen
at one week, the first time point measured, and sustained through
eight-week completion is very encouraging. The significant
reduction in HAM-D-17 with the 6.4
µg dose at the end of
the first week of treatment suggests that the antidepressant effect
of PH10 may have started even earlier than 1 week. Our plan for
Phase 2b development of PH10 in MDD includes a next-step study of
four weeks in duration, with an earlier initial measurement of
antidepressant effect, likely within the first 24 to 48 hours of
initial dose administration,” stated Mark
Smith, M.D., Ph.D., Chief
Medical Officer of VistaGen.
“Depression remains a highly prevalent and difficult to treat
mental illness, but we believe these data suggest a new path
forward in providing treatment for the millions of individuals with
MDD. The significant reduction in HAM-D-17 scores for the PH10 6.4
µg group versus the placebo group not only offers evidence of
PH10’s potential to be a fast-acting, easily administered MDD
treatment alternative, but also supports the nasal chemosensory
system as a novel way of delivering CNS active medications, which
is also relevant for VistaGen’s other neuroactive nasal
spray, PH94B for social anxiety disorder entering Phase 3
development later this year,” added Dr. Smith.
About VistaGen
VistaGen
Therapeutics is a multi-asset, clinical-stage biopharmaceutical
company developing new generation medicines for CNS diseases and
disorders where current treatments are inadequate, resulting in
high unmet need. VistaGen's pipeline is
focused on clinical-stage CNS drug candidates with a differentiated
mechanism of action, an exceptional safety profile, and therapeutic
potential in multiple large and growing CNS markets. For more
information, please visit www.vistagen.com
and connect with VistaGen on Twitter, LinkedIn and Facebook.
About PH10
PH10 is an investigational first-in-class, odorless, fast-acting
synthetic neurosteroid with therapeutic potential in a wide range
of neuropsychiatric indications involving depression and suicidal
ideation. VistaGen is initially developing PH10 as a potential
fast-acting, non-sedating, non-addictive new generation treatment
of MDD that can be conveniently self-administered at home. Upon
self-administration, a non-systemic microgram-level dose of PH10
sprayed into the nose binds to nasal chemosensory receptors that,
in turn, activate neural circuits in the brain that lead to
rapid-onset antidepressant effects, without side effects, systemic
exposure or safety concerns that may be caused by FDA-approved drug
treatments for MDD, including oral antidepressants and
esketamine. Following
successfully completed Phase 2a development for MDD,
VistaGen is
now preparing for planned Phase 2b clinical development of PH10 for
MDD.
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 candidate PH10 for MDD and multiple additional
depression-related disorders and suicidal ideation. In addition,
statements concerning the Company’s future expectations may
include statements regarding intellectual property and commercial
protection of each of our drug candidates. Each of these statements
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. Those risks
include the following: (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
studies may not be repeated or observed 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 any of our product candidates; (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 nonclinical and 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