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 3, 2018
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.
On October 3, 2018, the Company announced that the
U.S. Food and Drug Administration (“FDA”) granted Fast Track designation for
development of AV-101 as a non-opioid, non-sedating treatment for
neuropathic pain, the second FDA Fast Track designation granted to
the Company for development of AV-101 since December 2017. 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.
(d) Exhibits Index
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Exhibit No.
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Description
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Press
release issued by VistaGen Therapeutics Inc. dated October 3,
2018.
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Disclaimer.
This
Current Report on Form 8-K may contain, among other things, certain
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including, without
limitation, (i) statements with respect to the Company's plans,
objectives, expectations and intentions; and (ii) other statements
identified by words such as "may", "could", "would", should",
"believes", "expects", "anticipates", "estimates", "intends",
"plans" or similar expressions. These statements are based upon the
current beliefs and expectations of the Company's management and
are subject to significant risks and uncertainties.
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 5, 2018
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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 No.
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Description
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99.1
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Press
release issued by VistaGen Therapeutics Inc. dated October 3,
2018.
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Exhibit 99.1
VistaGen Therapeutics Receives FDA Fast Track Designation for
Development of AV-101 as a Non-Opioid Treatment for Neuropathic
Pain
Designation highlights serious unmet need for new treatment options
for patients suffering from neuropathic pain
Second FDA Fast Track designation for AV-101 since December 2017
marks another milestone for VistaGen's R&D
pipeline
SOUTH SAN FRANCISCO, Calif., October 3, 2018 –
VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
central nervous system (CNS) diseases and disorders with high unmet
need, today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation for
development of AV-101 as a non-opioid, non-sedating treatment for
neuropathic pain. This is the second FDA Fast Track designation
granted to VistaGen since December 2017.
The
FDA’s Fast Track designation is designed to facilitate the
development, and potentially expedite the review, of drugs to treat
serious or life-threatening conditions and fill an unmet medical
need.
AV-101
is an investigational, orally bioavailable, small molecule NMDA
(N-methyl-D-aspartate) receptor glycine B antagonist without
psychological or sedative side effects.
“Every
day in the U.S., more than 115 people
die from overdosing on opioids. We have
evaluated AV-101 in multiple models of serious CNS conditions,
including those that cause patients to suffer from neuropathic
pain, for which current treatment options are inadequate. After
considering peer-reviewed data published last year in The Journal
of Pain, together with published safety data from our Phase
1 program, we believe AV-101 has the potential to address the high
unmet need for a new non-opioid, non-sedating treatment for
neuropathic pain,” said
Shawn Singh, Chief Executive Officer of VistaGen.
“This important designation is especially timely given the
FDA’s forceful commitment to address our nation’s
opioid epidemic. The FDA’s Fast Track designation for
development of AV-101 for neuropathic pain, together with the
previously granted Fast Track designation for major depressive
disorder, will allow our team to work closely with the FDA to bring
AV-101 to patients affected by two of our country’s most
debilitating and widespread healthcare concerns as soon as
possible.”
VistaGen’s
receipt of the FDA’s Fast Track designation for the
development of AV-101 for neuropathic pain comes on the heels of
the recent official statement made by FDA Commissioner Scott
Gottlieb, stating that
the FDA
plans to issue guidance documents to assist sponsors with
the development of new non-opioid pain medications, such as AV-101,
as therapeutic alternatives to the use of opioids. More
specifically, over the next 6 to 12 months, the FDA has stated it
anticipates issuing several documents intended to stimulate the
development of medications for specific types of pain, resulting in
smaller clinical trials, faster approvals and quicker launches of
novel therapies.1
About Neuropathic Pain
Neuropathic
pain (NP) affects approximately 33 million people in the United
States (excluding patients with back pain).2 It is characterized by a steady burning
or "pins and needles" or "electric shock" sensation that results in
abnormal neuronal function after trauma to the nerve, viral
infections, certain medications, or metabolic insults.
About AV-101
AV-101
is an investigational, orally bioavailable, small molecule NMDA
(N-methyl-D-aspartate) receptor glycine B antagonist without
psychological or sedative side effects. AV-101 has potential to be
a new at-home treatment for multiple CNS indications with high
unmet need. AV-101 is currently in Phase 2 clinical development in
the United States for major depressive disorder (MDD). ELEVATE
ELEVATEis
VistaGen’s ongoing Phase 2 clinical trial designed to
evaluate the efficacy and safety of adjunctive use of AV-101 for
MDD in individuals with an inadequate response to standard
antidepressant therapy with either an FDA-approved SSRI or SNRI.
The FDA has granted Fast Track
designation for development of AV-101 as a potential
treatment of MDD and neuropathic pain.
About VistaGen
VistaGen
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
developing new generation medicines for multiple CNS diseases and
disorders with high unmet need. 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 of AV-101 and
the potential of AV-101 for the treatment of MDD, NP and various
other CNS diseases and disorders 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 in our ELEVATE study or other clinical studies that cause
us to discontinue further development of AV-101, (ii) we may not be
able to successfully demonstrate the safety and efficacy of AV-101
at each stage of clinical development, (iii) 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, (iv) decisions or actions of regulatory agencies
may negatively affect the initiation or progress of ongoing or
future AV-101 clinical trials, and our ability to proceed with
further clinical studies or to obtain marketing approval, (v) we
may not be able to obtain or maintain adequate intellectual
property protection and other forms of marketing and data
exclusivity for AV-101, (vi) we may not have access to or be able
to secure substantial additional capital required to support our
operations, including clinical development of AV-101 activities
described above; and (vii) we may encounter technical and other
unexpected hurdles in the manufacturing and development of AV-101.
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.
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
Media Contact
Caitlin
Kasunich / Lisa Lipson
KCSA
Strategic Communications
Phone:
+1 (212) 896-1241/+1 (508) 843-6428
Email: VistaGen@KCSA.com
1 https://www.washingtonpost.com/news/to-your-health/wp/2018/08/29/fda-pushes-for-development-of-non-opioid-pain-medications/?noredirect=on&utm_term=.99fa0f10ec06
2 DiBonaventura MD,
Sadosky A, Concialdi K, Hopps M, Kudel I, Parsons B, et al. The
prevalence of probable neuropathic pain in the US: results from a
multimodal general-population health survey. J Pain Res
2017;10:2525-2538.