VistaGen Therapeutics, a
clinical-stage biopharmaceutical company focused on developing innovative
medicine for depression and conditions associated with the central nervous
system, has entered into a Cooperative Research and Development Agreement
(CRADA) with the U.S. National Institute of Mental Health (NIMH), a component
of the U.S. National Institutes of Health (NIH). The CRADA enables VistaGen and
the NIMH to partner on an NIH-sponsored Phase 2 clinical study of AV-101 in
subjects with Major Depressive Disorder (MDD). MDD is a pervasive and
debilitating mental disorder which affects millions of people worldwide. It has
been noted that as many as 7% of all adults have some form of MDD.
Dr. Carlos Zarate, Chief
of the Section on the Neurobiology and Treatment of Mood Disorders and Chief of
the Experimental Therapeutics and Pathophysiology Branch at the NIMH, will be
the Principal Investigator of the NIH-funded study, which will be a randomized,
double-blind, placebo-controlled, crossover Phase 2 clinical trial designed to
study the efficacy and safety of an oral dose of AV-101 taken once per day for
two weeks. The study involves approximately 25 subjects with MDD. The main
efficacy measure will be the Hamilton Depression Rating Scale (HDRS) – the
subject standard for measuring the severity of MDD. The study is anticipated to
be completed this year.
Mr. H. Ralph Snodgrass,
VistaGen’s President and CSO, commented, “We are excited by the strong
preclinical efficacy data supporting the ketamine-like antidepressant effects
of AV-101, as well as the rapid and efficient oral-delivery and clinical safety
range demonstrated by our successful Phase 1 clinical studies. Dr. Zarate and
his team have deep experience with ketamine and other NMDA receptor
antagonists. We look forward to collaborating closely with them to complete
this important AV-101 Phase 2 study in MDD by year end.”
While the majority of
people will experience moods of depression at some point during their lives, it
should not be confused with clinically diagnosed MDD. MDD is the chronic,
pervasive feeling of unhappiness and suffering, impairing how one functions.
Symptoms of MDD include lower levels of pleasure in activities, insomnia or
hypersomnia, weight changes, fatigue, feelings of worthlessness and guilt, poor
concentration, suicidal thoughts and psychomotor agitation. It has been
estimated that suicide is the cause of death in as much as 15% of individuals
with MDD.
Current medications
available in the multi-billion dollar global antidepressant market are known to
have limited effectiveness. Because of this, their mechanism of action, SSRIs
and SNRIs, must be taken for several weeks before patients experience any
significant therapeutic benefit. Studies show that over 60% of depression
sufferers do not benefit from first round treatments, and the likelihood of
achieving remission of depressive symptoms declines with each successive
treatment attempt.
In the placebo-controlled,
double-blind clinical trials conducted by Dr. Zarate and others at the NIMH,
ketamine produced expedient antidepressant effects in MDD patients who had not
responded to approved antidepressants. Although the potential for widespread
therapeutic use of ketamine is limited by its potential for abuse, dissociative
and psychosis-like side effects, and practical challenges associated with its
required intravenous administration in a medical center, the discovery of
ketamine’s rapid onset antidepressant effects revolutionized thinking about the
MDD treatment paradigm and mechanism of action of antidepressant medicines. The
discovery also increased interest in the development of a new generation of
antidepressants with a mechanism of action similar to ketamine’s, including a
more rapid therapeutic benefit compared to existing agents.
AV-101’s fundamentally
novel mechanism of action places it among a new generation of glutamatergic
antidepressants with potential to address millions of MDD sufferers worldwide
who are poorly served by SSRIs, SNRIs and other current depression therapies.
Similar to ketamine, AV-101 down-regulates NMDA receptor channel activity.
However, unlike ketamine’s antagonistic activity, which results from its
blocking the NMDA receptor channel, AV-101’s antagonistic activity results from
its selective binding to, and blocking of, the functionally-required
glycine-binding co-agonist site of the NMDA receptor. Targeting the
glycine-binding co-agonist site of the NMDA receptor may bypass potential
adverse effects that occur with ketamine without affecting the robust efficacy
observed in previous clinical studies. This may then result in the “glutamate
surge” that has been associated with the rapid-acting antidepressant effects of
ketamine.
To date, NIH has awarded
VistaGen $8.8 million to advance its preclinical and Phase 1 clinical
development of AV-101. In two randomized, double-blind, placebo-controlled
Phase 1 safety studies, AV-101 was well tolerated and not associated with any
severe adverse events. There were no signs of sedation, hallucinations or
schizophrenia-like side effects often associated with ketamine and traditional
NMDA receptor channel blockers.
VistaGen is a
clinical-stage biopharmaceutical company developing innovative medicine for
depression and conditions involving the central nervous system. VistaGen’s
AV-101 is a new generation orally-available NMDA receptor glycine B-site
antagonist now moving into Phase 2 clinical development for MDD. Preclinical
studies to date have shown that AV-101 may also have potential as a treatment
for other CNS-related conditions, including chronic neuropathic pain and
epilepsy, Parkinson’s and Huntington’s disease. VistaGen is using its
proprietary pluripotent stem cell technology and clinically-predictive bioassay
systems, CardioSafe 3D™ and LiverSafe 3D™, for drug rescue applications focused
on producing proprietary, novel new chemical entities (NCEs) that are safer
versions of drug candidates previously optimized and tested for efficacy by
pharmaceutical companies.
For more information on
the company, visit www.vistagen.com
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