UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) of the SECURITIES EXCHANGE ACT OF
1934
Date of Report (Date of earliest event reported): April 5, 2018
VistaGen Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
|
NEVADA
|
001-37761
|
20-5093315
|
|
(State or other jurisdiction of incorporation)
|
(Commission File Number)
|
(IRS Employer Identification Number)
|
|
343 Allerton Ave.
South San Francisco, California 94090
|
|
(Address of principal executive offices)
|
(650) 577-3600
(Registrant’s telephone number, including area
code)
Not Applicable
(Former name or former address, if changed since last
report)
Check
the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2.
below):
☐
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
☐
Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
☐
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
☐
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (17
CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934
(17 CFR 240.12b-2) ☐
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act ☐
Item 8.01 Other Events.
VistaGen Therapeutics, Inc. (the
“Company”) today announced the initiation of
ELEVATE, the Company’s double-blind, placebo-controlled Phase
2 clinical study to evaluate the efficacy and safety of AV-101
(L-4-chlorokynurenine) as an adjunctive treatment of Major
Depressive Disorder (“MDD”) in patients with an inadequate response
to current antidepressants approved by the U.S. Food and Drug
Administration (“FDA”). AV-101, the Company’s oral
N-methyl-D-aspartate (“NMDA”) receptor glycine B
(“GlyB”) antagonist, belongs to a new generation
of investigational medicines in neuropsychiatry known as glutamate
receptor modulators that have the potential to treat MDD faster
than current FDA-approved antidepressants. A copy of the Company’s press release is
attached to this Current Report on Form 8-K as Exhibit 99.1 and is
incorporated by reference herein.
Item 9.01
Financial
Statements and Exhibits.
See
Exhibit Index.
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
|
|
VistaGen Therapeutics, Inc.
|
|
|
|
|
|
|
Date:
April 5, 2018
|
By:
|
/s/ Shawn K. Singh
|
|
|
|
Shawn K.
Singh
Chief Executive
Officer
|
EXHIBIT INDEX
|
Exhibit No.
|
|
Description
|
|
|
|
|
|
|
Press
Release issued by VistaGen Therapeutics, Inc., dated April 5,
2018
|
Exhibit
99.1
VistaGen Therapeutics Initiates Phase 2 Study of AV-101 for Major
Depressive Disorder
South San Francisco, CA (April 5, 2018) – VistaGen Therapeutics,
Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical
company developing new generation medicines for depression and
other central nervous system (CNS) disorders, today announced the
initiation of ELEVATE, the Company’s double-blind,
placebo-controlled Phase 2 clinical study to evaluate the efficacy
and safety of AV-101 (L-4-chlorokynurenine) as an adjunctive
treatment of Major Depressive Disorder (MDD) in patients with an
inadequate response to current antidepressants approved by the U.S.
Food and Drug Administration (FDA).
AV-101,
an oral N-methyl-D-aspartate (NMDA) receptor glycine B (GlyB)
antagonist, belongs to a new generation of investigational
medicines in neuropsychiatry known as glutamate receptor modulators
having the potential to treat MDD faster than current FDA-approved
antidepressants commonly known as
SSRIs and SNRIs, which target the neurotransmitters
serotonin and/or norepinephrine,
respectively.
“Major
Depressive Disorder is one of the most common diseases affecting
the U.S. population and many patients who suffer from it do not
respond adequately to currently available treatments,” said
Professor Maurizio Fava, M.D., Executive Vice Chair, Department of
Psychiatry, Massachusetts General Hospital (MGH) and Associate Dean
for Clinical & Translational Research, Harvard Medical School.
“This is an important clinical study given the properties of
AV-101. By studying AV-101, with its ability to be orally available
and to inhibit glutamatergic NMDA receptor activity through GlyB
site binding, we hope to improve clinical outcomes in depressed
patients with an inadequate response to standard antidepressant
therapies.”
”AV-101
has shown very promising results in preclinical antidepressant
models, with ketamine-like efficacy, but none of ketamine’s
side effects,” 1 said Mark A. Smith,
M.D., Ph.D., Chief Medical Officer of VistaGen Therapeutics.
“Building on excellent safety data from our Phase 1 clinical
program in which AV-101 was well-tolerated, with no psychotomimetic
or hallucinogenic side effects observed, we now have the
opportunity in our ELEVATE study to determine whether the exciting
preclinical efficacy will translate into beneficial effects for
patients with MDD and provide a safe and effective alternative to
existing adjunctive treatments for MDD, including atypical
antipsychotics, which have numerous potential side effects and
safety concerns.”
About ELEVATE
ELEVATE is
a Phase 2, randomized, double-blind, multi-center,
placebo-controlled clinical trial designed to examine the efficacy
and safety of adjunctive use of oral AV-101 for MDD in patients
with an inadequate response to standard antidepressant therapy with
either an FDA-approved selective serotonin reuptake inhibitor
(SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI).
Approximately 180 patients will be randomized to receive either
AV-101 or placebo, orally, once daily, in conjunction with their
ongoing antidepressant, for fourteen days. The primary endpoint of
the study is the change from baseline as measured by the
Montgomery-Asberg Depression Rating Scale (MADRS). Dr. Maurizio
Fava of Massachusetts General Hospital and Harvard Medical School
is the Principal Investigator of the study. Top-line results are
expected in the first half of 2019.
-[Insert
Page Number]-
About Major Depressive Disorder (MDD)
MDD is
a serious biologically-based mood disorder, affecting approximately
16 million adults in the United States.2 Individuals 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. About one in eight Americans aged 12 and over
takes an FDA-approved antidepressant.3 While current
FDA-approved antidepressants are widely used, about two-thirds of
patients with MDD do not respond to their initial antidepressant
treatment.4 Inadequate response
to current antidepressants is among the key reasons MDD is one of
the leading public health concerns in the United States, creating a
significant unmet medical need for new agents with fundamentally
different mechanisms of action.
About AV-101
AV-101 is an oral N-methyl-D-aspartate (NMDA) receptor glycine B
(GlyB) antagonist in Phase 2 clinical development in the United
States, initially as a new adjunctive treatment of MDD in patients
with an inadequate response to current FDA-approved
antidepressants. AV-101 has a novel mechanism of action (MOA),
meaning its MOA is fundamentally different from all current
FDA-approved treatments for depression. Most current FDA-approved
antidepressants, commonly known as SSRIs and SNRIs, target the
neurotransmitters serotonin and/or norepinephrine, respectively. If
effective, SSRIs and SNRIs take many weeks to achieve therapeutic
benefits. AV-101 targets glutamate, the most prevalent
neurotransmitter in the brain. Similar to intravenous ketamine, an NMDA receptor
antagonist which blocks activity of the NMDA receptor causing
psychotomimetic side effects and safety concerns, AV-101 inhibits
NMDA receptor activity and has the potential to achieve
ketamine-like antidepressant effects, but with oral administration
and without ketamine’s side effects and safety concerns.
AV-101 may also have the potential to treat neuropathic pain,
epilepsy, Parkinson's disease levodopa-induced dyskinesia, suicidal
ideation and other CNS diseases and disorders where modulation of
the NMDA receptors and activation of AMPA pathways may achieve
therapeutic benefits.
About VistaGen
VistaGen
Therapeutics, Inc. (NASDAQ: VTGN) is a clinical-stage
biopharmaceutical company developing new generation medicines for
depression and other CNS disorders. VistaGen’s lead CNS
product candidate, AV-101, is an oral NMDA receptor GlyB antagonist
in Phase 2 clinical development in the United States, initially as
a new adjunctive treatment of MDD in patients with an inadequate
response to current FDA-approved antidepressants. The FDA has granted Fast Track
designation to AV-101 for development as a potential adjunctive
treatment of MDD.
1 Zanos, P., et al. (2015) "The Prodrug
4-Chlorokynurenine Causes Ketamine-Like Antidepressant Effects, but
Not Side Effects, by NMDA/GlycineB-Site Inhibition." J
Pharmacol Exp Ther 355:76-85
2 Nat. Inst. of Mental Health website, 2017; Available at
https://www.nimh.nih.gov/health/statistics/major-depression.shtml.
3 Pratt LA, Brody
DJ, Gu Q. Antidepressant use among persons aged 12 and over:
United States, 2011–2014. NCHS data brief, no 283
(2017). www.cdc.gov/nchs/products/databriefs/db283.htm
4 Rush AJ, et al. Am J. Psychiatry. 2006, 163(11):
1905-1917 (STAR*D Study)
For
more information, please visit www.vistagen.com
and connect with VistaGen on Twitter,
LinkedIn and
Facebook.
Forward-Looking Statements
Various
statements in this release concerning VistaGen's future
expectations, plans and prospects, including without limitation,
our expectations regarding development of AV-101, the potential of
AV-101 for the treatment of MDD and various other CNS diseases and
disorders and the expected timing of data from the ELEVATE study
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, which could cause actual results to differ materially from
those contemplated in these forward-looking statements. Among these
risks is the possibility that we may encounter unexpected adverse
events in patients in the ELEVATE study that cause us to
discontinue further development of AV-101; we may not be able to
successfully demonstrate the safety and efficacy of AV-101 at each
stage of clinical development; success in preclinical studies
or in early-stage clinical trials may not be repeated or observed
in ongoing or future AV-101 studies, and ongoing or future
preclinical and clinical results may not support further
development of AV-101 or be sufficient to gain regulatory approval
to market AV-101; decisions or actions of regulatory agencies may
negatively affect the progress of the ELEVATE study or the
initiation, timing and progress of future AV-101 clinical trials,
and our ability to proceed with further clinical studies or to
obtain marketing approval; we may not be able to obtain or maintain
adequate intellectual property protection and other forms of
marketing and data exclusivity for AV-101; we may not have access
or be able to secure substantial additional capital to support our
operations, including clinical development of AV-101 activities
described above; and we may encounter technical and other
unexpected hurdles in the manufacturing and development of AV-101
or other product candidates, as well as those risks 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 filings with the
Securities and Exchange Commission (SEC), including the availability of substantial
additional capital to support our operations, including the AV-101
clinical development activities described above. 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 today, 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
###