SOUTH SAN FRANCISCO, Calif.,
Sept. 22, 2016 /PRNewswire/ --
VistaGen Therapeutics Inc. (NASDAQ: VTGN) (VistaGen or the
Company), a clinical-stage biopharmaceutical company
dedicated to developing and commercializing innovative product
candidates for patients with diseases and disorders involving the
central nervous system (CNS), today provided a business
outlook including the clinical status of its flagship CNS product
candidate, AV-101 (L-4-chlorokyurenine or 4-CI-KYN), currently in
Phase 2 development for the treatment of major depressive disorder
(MDD), and an overview of anticipated events and near-term
corporate, business, clinical and regulatory milestones expected
through the first half of 2017.
"During the first half of 2016, we have achieved notable
progress on corporate, clinical and regulatory fronts, and I
believe we are now rapidly heading into the most exciting time for
VistaGen to date," commented Shawn
Singh, Chief Executive Officer of VistaGen.
Recent Corporate Highlights
- Appointed Mark A. Smith M.D., Ph.D. as Chief Medical Officer,
former Clinical Lead for Neuropsychiatry at Teva Pharmaceuticals,
to lead clinical development of AV-101 in MDD and additional CNS
pipeline programs;
- Completed $10M public offering,
led by institutional investors;
- Uplisted to NASDAQ Capital Markets under new ticker
"VTGN";
- Appointed veteran healthcare executive, Jerry Gin, Ph.D., MBA, to Board of
Directors; and
- Bolstered Clinical and Regulatory Advisory Board (CRB)
with the appointment of existing member, Maurizio Fava, M.D., as Chairman, and new
members, Sanjay Matthew, M.D. and
Thomas Laughren M.D.
"These achievements were transformational for VistaGen. The
Company is fundamentally stronger than it ever has been, and we are
positioned to strategically expand our pipeline of opportunities in
the future," stated Mr. Singh.
Mr. Singh added, "The key appointments of our Chief Medical
Officer, Mark A. Smith, M.D., Ph.D.,
as well as the preeminent members to our Clinical and Regulatory
Advisory Board, position VistaGen at the forefront in the
development of the new generation of safer and orally available
antidepressants. Leveraging the strength and expertise of our
expanded team will prove to be an integral factor in unlocking and
building shareholder value, in both the short-term and
long-term."
AV-101 for the Adjunctive Treatment of MDD
– Clinical Development Overview
The Company also provided an update to its corporate progress
and clinical status for AV-101, its new generation, orally
available prodrug candidate in Phase 2 development, initially for
the adjunctive treatment of MDD in patients with an inadequate
response to standard antidepressants.
AV-101 is currently being evaluated in an ongoing Phase 2a
monotherapy study for the treatment of MDD, a study being conducted
and funded by the U.S. National Institute of Mental Health
(NIMH), part of the U.S. National Institutes of Health
(NIH). Dr. Carlos
Zarate of the NIMH is the Principal Investigator of the
study. AV-101's mechanism of action is fundamentally differentiated
from all FDA-approved antidepressants and atypical antipsychotics,
with potential to drive a paradigm shift towards new generation
safer and faster-acting antidepressants. VistaGen's development
strategy for AV-101 is focused on establishing it as the primary
augmentation option for individuals with MDD with inadequate
response to standard antidepressants, displacing atypical
antipsychotics in the current depression treatment paradigm.
VistaGen expects to report topline data from its NIMH-sponsored
Phase 2a study in the second quarter of 2017.
The Company is also preparing to advance AV-101 into a Phase 2b
study for adjunctive treatment of MDD in the first quarter of 2017.
Dr. Maurizio Fava of Harvard University will be the Principal
Investigator of this study. The double-blind, placebo controlled
efficacy and safety study of AV-101 as adjunctive treatment of MDD
for individuals with inadequate response to standard
antidepressants is expected to enroll approximately 280 patients at
20-25 sites across the US. The study will involve a Sequential
Parallel Comparison Design (SPCD), a study design intended
to mitigate placebo effects. The Company anticipates topline
results from this Phase 2b study to be reported in the third
quarter of 2018.
The Company expects to receive FDA Fast Track Designation for
AV-101 as adjunctive treatment for MDD during the first half of
2017.
Pipeline Expansion Opportunities
VistaGen believes it has the potential to expand AV-101 into
multiple additional CNS indications beyond adjunctive treatment of
MDD, including neuropsychiatric disorders (depression and bipolar
depression), neurological disorders (chronic neuropathic pain and
epilepsy) and neurodegenerative disorders (Huntington's disease and
Parkinson's disease), each representing potential blockbuster
opportunities.
The Company also evaluates opportunities to acquire or license
synergistic CNS product candidates to expand its
pipeline.
Near-Term Milestones Expected to Drive Value
- Meet with FDA and submit Investigational New Drug application
(IND) to the FDA regarding Phase 2b study of AV-101 as adjunctive
treatment of MDD in Q4 2016 (October – December 2016);
- Commence Phase 2b study of AV-101 as adjunctive treatment of
MDD in Q1 2017 (January - March
2017);
- Obtain FDA Fast Track Designation for AV-101 as adjunctive
treatment of MDD in Q1 2017 (January – March
2017); and
- Report topline data from NIMH-sponsored Phase 2a monotherapy
study of AV-101 in MDD in Q2 2017 (April - June 2017).
"We fully intend to build upon the significant momentum we have
created this year and will continue to focus on operational
excellence as we drive AV-101 towards late-stage clinical
development and commercialization. We believe AV-101 has the
potential to be a game-changing therapy for individuals living with
MDD where there remain significant shortcomings in current
treatment alternatives, and we are committed to advancing our
development programs as rapidly as possible. We believe AV-101 will
have an important role in the global depression market, a market
that is large and growing at staggering rates," Mr. Singh
concluded.
About Major Depressive Disorder
Depression is a
serious medical illness and a global public health concern that can
occur at any time over a person's life. While most people will
experience depressed mood at some point during their lifetime, MDD
is different. MDD is the chronic, pervasive feeling of utter
unhappiness and suffering, which impairs daily functioning.
Symptoms of MDD include diminished pleasure in activities, changes
in appetite that result in weight changes, insomnia or
oversleeping, psychomotor agitation, loss of energy or increased
fatigue, feelings of worthlessness or inappropriate guilt,
difficulty thinking, concentrating or making decisions, and
thoughts of death or suicide and attempts at suicide. Suicide is
estimated to be the cause of death in up to 15% individuals with
MDD. For many people, depression cannot be controlled for any
length of time without treatment. Standard antidepressant
medications currently available include commonly prescribed
selective serotonin reuptake inhibitors (SSRIs) and
serotonin-norepinephrine reuptake inhibitors (SNRIs).
However, about two out of every three drug-treated patients
suffering from MDD do not receive adequate therapeutic benefit from
their initial treatment with a standard, FDA-approved
antidepressant, and the likelihood of achieving remission declines
with each successive treatment attempt.
About AV-101
AV-101 (L-4-chlorokyurenine or 4-CI-KYN)
is an orally available prodrug candidate, currently in Phase 2
development, initially for the adjunctive treatment of major
depressive disorder (MDD) in patients with an inadequate response
to standard antidepressants. AV-101 has broad potential utility in
other CNS diseases and disorders, including chronic neuropathic
pain, epilepsy and neurodegenerative diseases, such as Parkinson's
disease and Huntington's disease. Orally available AV-101 is
rapidly absorbed through the gut, and then actively transported
across the blood-brain barrier. Astrocytes in the brain rapidly
convert AV‑101 into its active metabolite, 7-chlorokynurenic acid
(7-Cl-KYNA), a well-characterized, potent and selective antagonist
of N-methyl-D-aspartate (NMDA) receptors, acting by blocking the
glycine-binding co-agonist site of the NMDA receptor. AV-101 is a
member of a new generation of fast-acting glutamatergic drug
candidates in development for adjunctive treatment of MDD. These
fast-acting drug candidates act through the AMPA receptor pathway
increasing the production of nerve connections in the brain, often
referred to as "synaptogenesis." The increase in synaptogenesis is
thought to be the mechanism by which these new generation
antidepressant drug candidates have potential to provide
therapeutic benefit for MDD.
About VistaGen
VistaGen Therapeutics, Inc. is a
clinical-stage biopharmaceutical company dedicated to developing
and commercializing innovative product candidates for patients with
diseases and disorders involving the central nervous system (CNS).
VistaGen's lead CNS product candidate, AV-101, is a new generation,
orally available prodrug in Phase 2 development, initially for the
adjunctive treatment of MDD in patients with inadequate response to
standard antidepressants. AV-101 is currently being evaluated in an
ongoing Phase 2a clinical study being conducted by Principal
Investigator, Dr. Carlos Zarate,
Chief, Section on the Neurobiology and Treatment of Mood Disorders
and Chief of Experimental Therapeutics and Pathophysiology Branch
at the NIMH, and fully funded by the NIMH. VistaGen is also
preparing to initiate a Phase 2b clinical study of AV-101 as an
adjunctive treatment of MDD in the first quarter of 2017.
For more information, please visit www.vistagen.com and connect
with VistaGen on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
The statements in this
press release that are not historical facts may constitute
forward-looking statements that are based on current expectations
and are subject to risks and uncertainties that could cause actual
future results to differ materially from those expressed or implied
by such statements. Those risks and uncertainties include, but are
not limited to, risks related to VistaGen's successful Phase 2
clinical development of AV-101 for the treatment of MDD and other
CNS diseases and disorders, protection of its intellectual
property, and the availability of substantial additional capital to
support its operations, including the development activities
described above. These and other risks and uncertainties are
identified and described in more detail in VistaGen's filings with
the Securities and Exchange Commission (SEC). These filings
are available on the SEC's website at www.sec.gov. VistaGen
undertakes no obligation to publicly update or revise any
forward-looking statements.
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SOURCE VistaGen Therapeutics Inc.