Full Press Release Details
VistaGen Therapeutics Initiates Phase 2 Study of AV-101 for Major
South San Francisco, CA (April 5, 2018) VistaGen Therapeutics,
Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical
company developing new generation medicines for depression and
other central nervous system (CNS) disorders, today announced the
initiation of ELEVATE, the Company's double-blind,
placebo-controlled Phase 2 clinical study to evaluate the efficacy
and safety of AV-101 (L-4-chlorokynurenine) as an adjunctive
treatment of Major Depressive Disorder (MDD) in patients with an
inadequate response to current antidepressants approved by the U.S.
Food and Drug Administration (FDA).
an oral N-methyl-D-aspartate (NMDA) receptor glycine B (GlyB)
antagonist, 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
antidepressants commonly known as
SSRIs and SNRIs, which target the neurotransmitters
serotonin and/or norepinephrine,
Depressive Disorder is one of the most common diseases affecting
the U.S. population and many patients who suffer from it do not
respond adequately to currently available treatments, said
Professor Maurizio Fava, M.D., Executive Vice Chair, Department of
Psychiatry, Massachusetts General Hospital (MGH) and Associate Dean
for Clinical & Translational Research, Harvard Medical School.
This is an important clinical study given the properties of
AV-101. By studying AV-101, with its ability to be orally available
and to inhibit glutamatergic NMDA receptor activity through GlyB
site binding, we hope to improve clinical outcomes in depressed
patients with an inadequate response to standard antidepressant
has shown very promising results in preclinical antidepressant
models, with ketamine-like efficacy, but none of ketamine's
side effects, 1 said Mark A. Smith,
M.D., Ph.D., Chief Medical Officer of VistaGen Therapeutics.
Building on excellent safety data from our Phase 1 clinical
program in which AV-101 was well-tolerated, with no psychotomimetic
or hallucinogenic side effects observed, we now have the
opportunity in our ELEVATE study to determine whether the exciting
preclinical efficacy will translate into beneficial effects for
patients with MDD and provide a safe and effective alternative to
existing adjunctive treatments for MDD, including atypical
antipsychotics, which have numerous potential side effects and
a Phase 2, randomized, double-blind, multi-center,
placebo-controlled clinical trial designed to examine 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).
Approximately 180 patients will be randomized to receive either
AV-101 or placebo, orally, once daily, in conjunction with their
ongoing antidepressant, for fourteen days. The primary endpoint of
the study is the change from baseline as measured by the
Montgomery-Asberg Depression Rating Scale (MADRS). Dr. Maurizio
Fava of Massachusetts General Hospital and Harvard Medical School
is the Principal Investigator of the study. Top-line results are
expected in the first half of 2019.
About Major Depressive Disorder (MDD)
a serious biologically-based mood disorder, affecting approximately
16 million adults in the United States.2 Individuals with MDD
exhibit depressive symptoms, such as a depressed mood or a loss of
interest or pleasure in daily activities, for more than a two-week
period, as well as impaired social, occupational, educational or
other important functioning which has a negative impact on their
quality of life. About one in eight Americans aged 12 and over
takes an FDA-approved antidepressant.3 While current
FDA-approved antidepressants are widely used, about two-thirds of
patients with MDD do not respond to their initial antidepressant
treatment.4 Inadequate response
to current antidepressants is among the key reasons MDD is one of
the leading public health concerns in the United States, creating a
significant unmet medical need for new agents with fundamentally
different mechanisms of action.
AV-101 is an oral N-methyl-D-aspartate (NMDA) receptor glycine B
(GlyB) antagonist in Phase 2 clinical development in the United
States, initially as a new adjunctive treatment of MDD in patients
with an inadequate response to current FDA-approved
antidepressants. AV-101 has a novel mechanism of action (MOA),
meaning its MOA is fundamentally different from all current
FDA-approved treatments for depression. Most current FDA-approved
antidepressants, commonly known as SSRIs and SNRIs, target the
neurotransmitters serotonin and/or norepinephrine, respectively. If
effective, SSRIs and SNRIs take many weeks to achieve therapeutic
benefits. AV-101 targets glutamate, the most prevalent
neurotransmitter in the brain. Similar to intravenous ketamine, an NMDA receptor
antagonist which blocks activity of the NMDA receptor causing
psychotomimetic side effects and safety concerns, AV-101 inhibits
NMDA receptor activity and has the potential to achieve
ketamine-like antidepressant effects, but with oral administration
and without 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.
Therapeutics, Inc. (NASDAQ: VTGN) is a clinical-stage
biopharmaceutical company developing new generation medicines for
depression and other CNS disorders. VistaGen's lead CNS
product candidate, AV-101, is an oral NMDA receptor GlyB antagonist
in Phase 2 clinical development in the United States, initially as
a new adjunctive treatment of MDD in patients with an inadequate
response to current FDA-approved antidepressants. The FDA has granted Fast Track