SOUTH SAN FRANCISCO, Calif.,
Feb. 20, 2020 /PRNewswire/
-- 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.
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SOURCE VistaGen Therapeutics