SOUTH SAN FRANCISCO, Calif.,
Oct. 8, 2019 /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
need, announced today that the last patient has completed dosing in
the ELEVATE Phase 2 clinical study of AV-101, the Company's novel,
oral NMDA (N-methyl-D-aspartate) receptor glycine site antagonist,
as an adjunctive (add-on) treatment with an FDA-approved oral
antidepressant for major depressive disorder (MDD). The Company
remains on track to report top line results of the ELEVATE study
before the end of 2019.
About AV-101
AV-101 (4-Cl-KYN) belongs to a new
generation of investigational medicines in neuropsychiatry and
neurology known as NMDA glutamate receptor modulators. The NMDA
receptor is a pivotal receptor in the brain and abnormal NMDA
function is associated with numerous CNS diseases and disorders.
AV-101 is an oral prodrug of 7-Cl-KYNA, a potent and selective full
antagonist of the glycine coagonist site of the NMDA receptor. With
its exceptional safety profile in all studies to date, AV-101 has
potential to be a new at-home treatment for multiple large market
CNS indications where current treatments are inadequate to satisfy
high unmet patient needs. VistaGen is currently focused on AV-101's
potential to treat depression, dyskinesia associated with levodopa
therapy for Parkinson's disease, epilepsy, neuropathic pain and
suicidal ideation. The FDA has granted Fast Track designation for
development of AV-101 as a potential adjunctive treatment for
MDD and as a non-opioid treatment for neuropathic
pain.
About the ELEVATE Study
Among VistaGen's key objectives for AV-101 in MDD is to replace
atypical antipsychotics in the current MDD drug treatment paradigm
and redefine the standard of care for individuals who are unable to
reduce their symptoms of depression with their current oral
antidepressant alone. The ELEVATE study is VistaGen's U.S.
multi-center, randomized, double-blind, placebo-controlled Phase 2
clinical study to evaluate the efficacy and safety of adjunctive
use of AV-101 in adult MDD patients who have an inadequate response
to standard FDA-approved oral antidepressant therapy. VistaGen
achieved target enrollment (n = 180) in the ELEVATE study in
August 2019. The primary endpoint of
the ELEVATE study is the change from baseline on the
Montgomery-Åsberg Depression Rating Scale (MADRS-10) total
score.
About Major Depressive Disorder (MDD)
MDD is a serious neurobiologically-based mood disorder, affecting
approximately 17.3 million adults in the U.S., or 7.1% of the U.S.
adult population, according to the U.S. National Institute of
Mental Health. Individuals diagnosed with MDD exhibit depressive
symptoms, such as a depressed mood or a loss of interest or
pleasure in daily activities, for more than a two-week period, as
well as impaired social, occupational, educational or other
important functioning which has a negative impact on their quality
of life. Globally, MDD affects nearly 300 million people of all
ages and is the leading cause of disability according to the World
Health Organization.
About VistaGen
VistaGen Therapeutics is a
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 includes three differentiated,
clinical-stage CNS drug candidates, AV-101, PH10 and PH94B, each
with an exceptional safety profile in all clinical studies to date
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.
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 three drug
candidates, (i) AV-101 for depression, dyskinesia associated with
levodopa therapy for Parkinson's disease, epilepsy, neuropathic
pain and suicidal ideation ; (ii) PH94B for social anxiety
disorder, generalized anxiety disorder, peripartum anxiety,
preoperative anxiety, panic disorder and post-traumatic stress
disorder; and (iii) PH10 for MDD, peripartum depression and
suicidal ideation. In addition, statements concerning the Company's
future expectations may include statements regarding intellectual
property and commercial protection 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. 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, including for AV-101 during the
ELEVATE study, (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, (iv)
decisions or actions of regulatory agencies may negatively affect
the progress of, and our ability to proceed with, 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 required 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.
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SOURCE VistaGen Therapeutics