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): October 26, 2017
VistaGen Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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NEVADA
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001-37761
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20-5093315
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification Number)
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343 Allerton Ave.
South San Francisco, California 94090
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(Address of principal executive offices)
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(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:
☐ 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))
Item 8.01 Other Events.
VistaGen Therapeutics, Inc. (the
“Company”) today announced that the U.S. Food and
Drug Administration has authorized the Company to proceed, under
its Investigational New Drug application, with its planned Phase 2
clinical study of AV-101 as a new generation oral treatment for
major depressive disorder. A copy of the press release is
attached to this Current Report on Form 8-K as Exhibit 99.1, and is
incorporated herein by reference.
Item 9.01 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.
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VistaGen
Therapeutics, Inc.
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Date:
October 26, 2017
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By:
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/s/ Shawn K. Singh
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Shawn
K. Singh
Chief
Executive Officer
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EXHIBIT INDEX
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Exhibit Number
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Description
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Press
release issued by VistaGen Therapeutics Inc., dated October 26,
2017.
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VistaGen Announces FDA Authorization to Initiate Phase 2
Study
of AV-101 for Major Depressive Disorder
South San Francisco, CA (October 26, 2017) – VistaGen
Therapeutics Inc. (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company focused on developing new generation
medicines for depression and other central nervous system (CNS)
disorders, announced today that the U.S. Food and Drug
Administration (FDA) has authorized the Company to proceed, under
its Investigational New Drug (IND) application, with its planned
Phase 2 clinical study of AV-101 as a new generation oral treatment
for major depressive disorder (MDD).
VistaGen
is preparing to launch a 180-patient, multi-center, double-blind,
placebo-controlled Phase 2 study to assess the safety, tolerability
and efficacy of AV-101 as an orally administered adjunctive
treatment for adult MDD patients with an inadequate response to
standard, FDA-approved antidepressants. Dr. Maurizio Fava of
Harvard Medical School will be the Principal Investigator of this
study, expected to begin in the first quarter of 2018.
“This
is a significant milestone in our AV-101 clinical development
program,” stated Shawn Singh, Chief Executive Officer of
VistaGen. “With the FDA’s authorization to proceed
under our IND application now in hand, our primary goal remains to
launch and complete our Phase 2 study of AV-101 for major
depressive disorder in 2018, further advancing our efforts to
develop and commercialize AV-101 as a new generation oral treatment
alternative for depression, one with a mechanism of action that is
fundamentally differentiated from all FDA-approved antidepressants
and atypical antipsychotics often used adjunctively to augment
them.”
About AV-101
AV-101
(4-CI-KYN) is an oral CNS drug candidate in Phase 2 development in
the U.S., initially as a new generation adjunctive treatment for
MDD. AV-101 also has broad potential utility in several other CNS
indications where modulation of NMDA receptors, activation of AMPA
pathways and/or key active metabolites of AV-101 may achieve
therapeutic benefit, including neuropathic pain and epilepsy, as
well as addressing symptoms associated with neurodegenerative
diseases, such as Parkinson's disease levodopa-induced dyskinesia
(PD LID) and Huntington's disease.
AV-101
is currently being evaluated in a Phase 2 monotherapy study in MDD,
a study being fully funded by the U.S. National Institute of Mental
Health (NIMH) and conducted by Dr. Carlos Zarate Jr., Chief,
Section on the Neurobiology and Treatment of Mood Disorders and
Chief of Experimental Therapeutics and Pathophysiology Branch at
the NIMH, as Principal Investigator.
VistaGen
is preparing to advance AV-101 into a 180-patient, U.S.
multi-center, Phase 2 adjunctive treatment study in adult MDD
patients with an inadequate response to standard, FDA-approved
antidepressants, with Dr. Maurizio Fava of Harvard University as
Principal Investigator.
About VistaGen
VistaGen
Therapeutics, Inc. (NASDAQ: VTGN) is a clinical-stage
biopharmaceutical company focused on developing new generation
medicines for depression and other CNS disorders. VistaGen's lead
CNS product candidate, AV-101, is in Phase 2 development, initially
as a new generation oral antidepressant drug candidate for MDD.
AV-101's mechanism of action is fundamentally different from all
FDA-approved antidepressants and atypical antipsychotics used
adjunctively to treat MDD, with potential to drive a paradigm shift
towards a new generation of safer and faster-acting
antidepressants. AV-101 is currently being evaluated by the NIMH in
a small Phase 2 monotherapy study in MDD being fully funded by the
NIMH and conducted by Dr. Carlos Zarate Jr., Chief, Section on the
Neurobiology and Treatment of Mood Disorders and Chief of
Experimental Therapeutics and Pathophysiology Branch at the NIMH.
VistaGen is preparing to launch a 180-patient Phase 2 study of
AV-101 as an adjunctive treatment for MDD patients with an
inadequate response to standard, FDA-approved antidepressants, with
Dr. Maurizio Fava of Harvard University as Principal Investigator.
AV-101 may also have the potential to treat multiple CNS disorders
and neurodegenerative diseases in addition to MDD, including
neuropathic pain, epilepsy, Huntington's disease, PD LID and other
disorders where modulation of the NMDA receptors, activation of
AMPA pathways and/or key active metabolites of AV-101 may achieve
therapeutic benefit.
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 the
successful funding, launch, continuation and results of the NIMH's
Phase 2 (monotherapy) and/or the Company's planned Phase 2
(adjunctive treatment) clinical studies of AV-101 in MDD, and other
CNS diseases and disorders, including neuropathic pain and PD LID,
protection of its intellectual property, and the availability of
substantial additional capital to support its operations, including
the AV-101 Phase 2 adjunctive treatment study and other potential
AV-101 clinical 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.
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
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