VistaGen Therapeutics Issued Two Key U.S. Patents for Treatment of Depression with AV-101
June 13 2018 - 8:30AM
VistaGen Therapeutics, Inc. (NASDAQ:VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
depression and other central nervous system (CNS) diseases and
disorders, today announced that the U.S. Patent and Trademark
Office (USPTO) has issued the following two key U.S. patents
related to AV-101, VistaGen’s oral new generation CNS product
candidate in Phase 2 development for treatment of Major Depressive
Disorder (MDD):
- U.S. Patent No. 9,993,453 related to AV-101’s therapeutic uses
to treat depression; and
- U.S. Patent No. 9,993,450 related to AV-101’s oral dosage
formulations.
The two new AV-101 U.S. patents above will not expire until at
least 2034.
"The issuance of these U.S. patents is a fundamental advancement
of our plan to secure commercial exclusivity for AV-101 in the
world’s major pharmaceutical markets," stated Shawn Singh, Chief
Executive Officer of VistaGen. “Our primary goal is to develop and
commercialize AV-101 as an oral new generation antidepressant for
convenient at-home use. We believe oral administration provides
greater flexibility for location of care, which is optimal for
people suffering with MDD, and the potential of rapid onset of
symptom reduction can provide life-changing benefits for millions
of people. Today’s U.S. patent issuances and the initiation earlier
this year of ELEVATE, our U.S. multi-center Phase 2 study of AV-101
in MDD, are milestones in our AV-101 MDD program, each a
significant step forward in our efforts to provide new treatment
alternatives to millions of people battling depression and its
consequences every day.”
About AV-101
AV-101 is an oral N-methyl-D-aspartate receptor glycine B (NMDAR
GlyB) antagonist in Phase 2 clinical development in the United
States. ELEVATE is VistaGen’s ongoing Phase 2, multi-center,
randomized, double-blind, placebo-controlled clinical trial
designed to evaluate 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). Dr. Maurizio Fava of
Massachusetts General Hospital and Harvard Medical School is the
Principal Investigator of VistaGen’s ELEVATE study.
AV-101 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 SSRIs
and SNRIs. AV-101’s mechanism of action (MOA) is fundamentally
different from all current FDA-approved SSRIs and SNRIs for
depression, most of which, if effective for a given patient, take
many weeks to achieve therapeutic benefits. AV-101 targets a
receptor for glutamate, the most prevalent neurotransmitter in the
brain. AV-101 inhibits NMDA receptor activity, activates AMPA
pathways and has the potential to achieve ketamine-like
antidepressant effects as an oral drug candidate for at-home use
that does not cause 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. The FDA has granted Fast Track designation to
AV-101 for development as a potential adjunctive treatment of
MDD.
About VistaGen
VistaGen Therapeutics, Inc. is a clinical-stage
biopharmaceutical company developing new generation medicines for
depression and other CNS diseases and disorders with high unmet
need. VistaGen's lead CNS product candidate, AV-101, is an oral
NMDAR GlyB antagonist in Phase 2 clinical development in the United
States for MDD and other CNS indications.
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, the
potential of AV-101 for the treatment of MDD and various other CNS
diseases and disorders and our intellectual property and commercial
protection of AV-101 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 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 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, (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 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 or other 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.
Company Contact
Mark A. McPartlandVistaGen Therapeutics Inc.Phone: +1 (650)
577-3600Email: IR@vistagen.com
Investor Contact
Valter Pinto / Allison SossKCSA Strategic CommunicationsPhone:
+1 (212) 896-1254/+1 (212) 896-1267Email: VistaGen@KCSA.com
Media Contact
Caitlin Kasunich / Lisa LipsonKCSA Strategic
CommunicationsPhone: +1 (212) 896-1241/+1 (508) 843-6428Email:
VistaGen@KCSA.com
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