Vistagen Announces Publication in Cells Demonstrating AV-101’s Potential for Treating Levodopa-Induced Dyskinesia in Patients with Parkinson's Disease
November 17 2022 - 8:30AM
Business Wire
Preclinical data in "gold standard" MPTP non-human primate model
of Parkinson's disease show significant reduction of
levodopa-induced dyskinesia by AV-101, while maintaining
antiparkinsonian activity of levodopa
Vistagen (NASDAQ: VTGN) a late clinical-stage biopharmaceutical
company aiming to transform the treatment landscape for individuals
living with anxiety, depression and other central nervous system
(CNS) disorders, today announced the publication of positive
results from a preclinical study of the effects of AV-101, its oral
NMDA receptor glycine site antagonist, in a widely used MPTP
non-human primate model for reproducing motor complications of
Parkinson's disease (PD), including dyskinesia (sudden uncontrolled
movements) observed in PD patients treated with levodopa (L-Dopa).
Findings from the preclinical study were published in the
international, peer-reviewed journal, Cells. In the preclinical
study, AV-101 reduced L-Dopa-induced dyskinesias (LID) by about 25%
while maintaining the antiparkinsonian response to L-Dopa.
“While L-Dopa remains the most effective pharmacotherapy for
Parkinson’s disease, the occurrence of LID is difficult to manage
and drastically interferes with Parkinson’s patients’ quality of
life. This preclinical study showed that AV-101 reduced LID with no
adverse effects of treatment,” stated Shawn Singh, Chief Executive
Officer of Vistagen. “Dr. Di Paolo has been at the forefront of
research in neuropharmacology and treatments for Parkinson’s
disease for decades. Her preclinical data from this study are
compelling and highlight AV-101’s potential to improve the
treatment paradigm for LID associated with Parkinson’s therapy by
reducing LID while still maintaining the antiparkinsonian activity
of L-Dopa.”
The MPTP primate model used in this study is the "gold standard"
for animal modeling of PD and has been used extensively to study
both antiparkinsonian therapies and LID. MPTP is a neurotoxin that
kills dopaminergic neurons in the striatum, producing motor
symptoms similar to those of PD. In this study, AV-101's efficacy
against LID was measured through behavioral scores on a dyskinesia
scale, and a Parkinsonian disability scale was used to measure
levodopa antiparkinsonian efficacy. This study demonstrated that
AV-101 significantly (p = 0.01) reduced LID without affecting the
timing, extent, or duration of the therapeutic benefits of
levodopa. No adverse events attributable to the drug were observed
during the study. This preclinical study was conducted by Dr.
Thérèse Di Paolo, Emeritus Professor in the Faculty of Pharmacy at
Laval University and among the world's leading researchers focused
on Parkinson's disease and LID, pursuant to Vistagen's research
agreement with CHU de Québec – Université Laval Research Center in
Québec, Canada.
The article is entitled “AV-101, a Pro-Drug Antagonist at the
NMDA Receptor Glycine Site, Reduces L-Dopa Induced Dyskinesias in
MPTP Monkeys,” and is available online at:
https://doi.org/10.3390/cells11223530
The U.S. Patent and Trademark Office (USPTO) has issued US
Patent No. 10,632,091 related to therapeutic use of AV-101 for
treatment of dyskinesia induced by the administration of L-Dopa.
The patent will be in effect until at least 2034.
About AV-101
AV-101 (4-chlorokynurenine) is an oral prodrug of
7-chloro-kynurenic acid (7-Cl-KYNA), which is a potent and
selective full antagonist of the glycine co-agonist site of the
NMDA receptor (NMDAR) that inhibits certain functions of the NMDAR.
Unlike ketamine and many other NMDAR antagonists, 7-Cl-KYNA is not
an ion channel blocker. At doses administered in studies completed
to date, AV-101 has been observed to be well tolerated and has not
exhibited dissociative or hallucinogenic psychological side effects
or safety concerns, unlike other modulators of the NMDAR. Based on
observations and findings from preclinical studies, Vistagen
believes that AV-101, alone or in combination with FDA-approved
oral probenecid, has the potential to become a new oral treatment
alternative for certain CNS disorders involving the NMDAR. Vistagen
is presently conducting an exploratory Phase 1B drug-drug
interaction clinical study of AV-101 in combination with
probenecid. The FDA has granted Fast Track designation for
development of AV-101 as a potential adjunctive treatment for MDD
and as a non-opioid treatment for neuropathic pain.
About Vistagen
Vistagen (Nasdaq: VTGN) is a late clinical-stage CNS-focused
biopharmaceutical company aiming to transform the treatment
landscape for individuals living with anxiety, depression and other
CNS disorders. The Company is advancing therapeutics with the
potential to be faster-acting, and with fewer side effects and
safety concerns, than those that are currently available.
Vistagen’s clinical-stage candidates are targeting multiple forms
of anxiety and depression. PH94B and PH10 belong to a new class of
drugs known as pherines, which are odorless and tasteless
investigational neuroactive steroids designed with a novel
rapid-onset mechanism of action that activates chemosensory neurons
in the nasal passages and can impact the olfactory-amygdala neural
circuits without systemic uptake or direct activity on CNS neurons
in the brain. Vistagen is passionate about transforming mental
health care and redefining what is possible in the treatment of
anxiety and depression. Connect at www.Vistagen.com.
Forward Looking Statements
This press release contains certain forward-looking statements
within the meaning of the federal securities laws. These
forward-looking statements involve known and unknown risks that are
difficult to predict and include all matters that are not
historical facts. In some cases, you can identify forward-looking
statements by the use of words such as “may,” “could,” “expect,”
“project,” “outlook,” “strategy,” “intend,” “plan,” “seek,”
“anticipate,” “believe,” “estimate,” “predict,” “potential,”
“strive,” “goal,” “continue,” “likely,” “will,” “would” and
variations of these terms and similar expressions, or the negative
of these terms or similar expressions. Such forward-looking
statements are necessarily based upon estimates and assumptions
that, while considered reasonable by Vistagen and its management,
are inherently uncertain. As with all pharmaceutical products,
there are substantial risks and uncertainties in the process of
development and commercialization and actual results or
developments may differ materially from those projected or implied
in these forward-looking statements. Among other things, there can
be no guarantee that any of the Company’s drug candidates will
successfully complete ongoing or future clinical trials, receive
regulatory approval or be commercially successful. Other factors
that may cause such a difference include, without limitation, risks
and uncertainties relating to development of AV-101 and the
Company’s other product candidates, PH94B and PH10; delays in
launching, conducting and/or completing other ongoing and planned
clinical trials; fluctuating costs of materials and other resources
required to conduct the Company’s ongoing and/or planned clinical
and non-clinical trials; market conditions; the impact of general
economic, industry or political conditions in the United States or
internationally; and other technical and unexpected hurdles in the
development, manufacture and commercialization of the Company’s CNS
drug candidates. These risks are more fully discussed in the
section entitled "Risk Factors" in the Company’s most recent Annual
Report on Form 10-K for the fiscal year ended March 31, 2022 and in
the Company’s most recent Quarterly Report on Form 10-Q for the
quarter ended September 30, 2022, as well as discussions of
potential risks, uncertainties, and other important factors in our
other filings with the U.S. Securities and Exchange Commission
(SEC). The Company’s SEC filings are available on the SEC’s website
at www.sec.gov. You should not place undue reliance on these
forward-looking statements, which apply only as of the date of this
press release and should not be relied upon as representing the
Company’s views as of any subsequent date. The Company explicitly
disclaims any obligation to update any forward-looking statements,
other than as may be required by law. If the Company does update
one or more forward-looking statements, no inference should be made
that the Company will make additional updates with respect to those
or other forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20221117005483/en/
Investors Mark Flather Vice President, Investor Relations
Phone: (650) 577-3617 Email: mflather@vistagen.com
Media Nate Hitchings SKDK Email:
nhitchings@skdknick.com
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