SOUTH SAN FRANCISCO, Calif.,
May 27, 2020 /PRNewswire/
-- VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
anxiety, depression and other central nervous system (CNS) diseases
and disorders with high unmet need, and Nuformix plc (LSE: NFX.L),
a pharmaceutical development company focused on unlocking the
therapeutic potential and value of known drugs, today announced
their agreement to develop novel cocrystal-based formulations of
VistaGen's CNS product candidates. Under the terms of the
agreement, VistaGen and Nuformix initially will
apply Nuformix's proprietary technology platform to develop
patentable new crystalline forms of AV-101 that may have superior
delivery, an enhanced therapeutic profile and additional
intellectual property protection. If successful, VistaGen
and Nuformix will consider opportunities to extend the
collaboration to other CNS therapeutic candidates with a view
to unlocking additional therapeutic and commercial
opportunities.
"Nuformix has a successful track record of using cocrystal
technology to re-engineer the crystalline form of small molecule
drugs for their own development and for select partners," said H.
Ralph Snodgrass, PhD, VistaGen
President and Chief Scientific Officer. "Their team is not only
highly experienced, but also scientifically creative. We look
forward to a productive collaboration."
"We're very pleased to announce this collaboration with VistaGen
and the opportunity to collaborate in CNS therapeutics," said
Dan Gooding, PhD, Nuformix Chief
Executive Officer. "VistaGen and Nuformix share similar objectives
in the development of new therapies and we look forward to making
an important contribution to VistaGen's comprehensive AV-101
programme and developing the relationship further."
AV-101 is VistaGen's oral NMDAR (N-methyl-D-aspartate receptor)
glycine site antagonist, in development in combination with
probenecid, a safe and well-known oral drug used to treat gout and
to increase the therapeutic benefit of numerous antibacterial,
anticancer and antiviral drugs. Recently reported preclinical
data suggest that there is a substantially increased brain
concentration of AV-101 prodrug (4-Cl-KYN) and its active
metabolite, 7-chlorokynurenic acid (7-Cl-KYNA), when given together
with probenecid. With its exceptionally few side effects and
excellent safety profile in all clinical studies to date, AV-101,
together with probenecid, has potential to be a new generation oral
treatment for chronic neuropathic pain, epilepsy, levodopa-induced
dyskinesia associated with Parkinson's disease therapy, major
depressive disorder, and suicidal ideation.
About AV-101
AV-101 (4-Cl-KYN) targets the NMDAR
(N-methyl-D-aspartate receptor), an ionotropic glutamate receptor
in the brain. Abnormal NMDAR function is associated with
numerous CNS diseases and disorders. AV-101 is an oral prodrug of
7-chlorokynurenic acid (7-Cl-KYNA), which is a potent and selective
full antagonist of the glycine co-agonist site of the NMDAR that
inhibits the function of the NMDAR. Unlike ketamine and many other
NMDAR antagonists, 7-Cl-KYNA is not an ion channel blocker. In all
studies to date, AV-101 has exhibited no dissociative or
hallucinogenic psychological side effects or safety concerns
similar to those that may be caused by amantadine, esketamine and
ketamine. With its exceptionally few side effects and
excellent safety profile, AV-101 has potential to be an oral new
generation treatment for multiple large-market CNS indications
where current treatments are inadequate to meet high unmet patient
needs. The FDA has granted Fast Track designation for development
of AV-101 as both a potential adjunctive treatment for
MDD and as a non-opioid treatment for neuropathic
pain.
About Cocrystals
Pharmaceutical cocrystals are
materials composed of two or more different molecules, usually an
active pharmaceutical ingredient together with a "co-former"
molecule. Cocrystals can be engineered to enhance the
bioavailability, pharmacokinetics, stability and manufacturing of
drug products.
About VistaGen
VistaGen Therapeutics is a multi-asset,
clinical-stage biopharmaceutical company developing new generation
medicines for anxiety, depression and certain CNS diseases and
disorders where current treatments are inadequate, resulting in
high unmet need. VistaGen's pipeline is focused on three
clinical-stage CNS drug candidates, each with a differentiated
mechanism of action, an exceptional safety profile, and therapeutic
potential in multiple large and growing CNS markets. For more
information, please visit www.vistagen.com and connect with
VistaGen on Twitter, LinkedIn and Facebook.
About Nuformix
Nuformix is a pharmaceutical
development company focused on unlocking the therapeutic potential
and value of known drugs. Nuformix risk-mitigated development
strategy has resulted in a pipeline of discoveries through which it
has developed and patented novel forms of approved small molecules.
Nuformix is targeting high-value unmet needs via drug repurposing
with a lead programme in fibrosis (NXP002). Nuformix plc shares are
traded on the London Stock Exchange's Official List under the
ticker: NFX. For more information please visit
www.nuformix.com.
VistaGen Forward-Looking Statements
This release
contains various statements concerning VistaGen's future
expectations, plans and prospects, including without limitation,
our expectations regarding discovery, development and
commercialization of patentable cocrystalline forms of AV-101,
either alone or in combination with probenecid, for treatment of
CNS diseases and disorders with high unmet need, including chronic
neuropathic pain, epilepsy, levodopa-induced dyskinesia associated
with Parkinson's disease therapy, major depressive disorder, and
suicidal ideation. In addition, statements concerning the
Company's future expectations may include statements regarding
intellectual property and commercial protection of our drug
candidates. Each of these statements 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. Those risks include the
following: (i) we may encounter unexpected adverse events in
patients during our clinical development of any product candidate
that cause us to discontinue further development; (ii) we may not
be able to successfully demonstrate the safety and efficacy of our
product candidates at each stage of clinical development; (iii)
success in preclinical studies or in early-stage clinical trials
may not be repeated or observed future studies, and ongoing or
future preclinical and clinical results may not support further
development of, or be sufficient to gain regulatory approval to
market AV-101; (iv) decisions or actions of regulatory agencies may
negatively affect the progress of, and our ability to proceed with,
further clinical studies or to obtain marketing approval for our
drug candidates; (v) we may not be able to obtain or maintain
adequate intellectual property protection and other forms of
marketing and data exclusivity for our product candidates; (vi) we
may not have access to or be able to secure the substantial
additional capital necessary to support our operations, including
our ongoing and/or planned preclinical and/or clinical development
studies; and (vii) we may encounter technical and other unexpected
hurdles and delays in the manufacturing and development of any of
our 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.
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SOURCE VistaGen Therapeutics