Full Press Release Details
VistaGen and Nuformix Announce Agreement to Develop Novel
Patentable Cocrystalline Forms of AV-101 for Treatment of Multiple
Novel Cocrystal Form of AV-101 Administered with
May Have Superior Delivery, an Enhanced Therapeutic
and Additional Intellectual Property Protection
SOUTH SAN FRANCISCO, Calif., May 27, 2020 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
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
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
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
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
a non-opioid treatment
for neuropathic pain.
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.
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.
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