Millions of people around the world suffer from depression,
which ranges from short-lived emotional responses to something as severe as
suicide, positioning the mental disease as the leading cause of disability
worldwide and a dire global health concern.
While recommended depression treatment options range from
psychosocial support combined with antidepressant medication or psychotherapy,
scientists are seeking new, rapid-acting and more effective treatments than
those currently offered in the marketplace.
The World Health Organization (WHO) estimates that globally
350 million people suffer from depression, prompting the organization in 2012
to call for a comprehensive, coordinated response to metal disorders at a
country level. The WHO’s Mental Health Gap Action Programme (mhGAP) aims to
help countries utilize proper care, psychosocial assistance and medication to
increase services for people with mental, neurological and substance abuse
disorders.
Here in the states, the U.S. National Institutes of Health
(NIH) has conducted clinical trials of ketamine, an FDA-approved anesthetic and
adversely used street drug, as a potential antidepressant. While ketamine
demonstrates the ability to rapidly alleviate symptoms of depression – compared
to current treatments which can take weeks before any therapeutic benefit is
achieved – widespread clinical use of ketamine is severely limited due to its
high risk for abuse and behavioral impairment, hallucinogenic and
schizophrenic-like side effects, and inconvenient intravenous administration in
a medical center.
Still, ketamine’s astounding antidepressant benefits have
motivated biopharmaceutical companies like VistaGen Therapeutics to
aggressively pursue a breakthrough new generation of depression medications.
VistaGen is developing AV-101, a novel, potent and orally-
active NMDA receptor (NMDAR) glycine-binding site antagonist. In preclinical
studies involving the NIH, AV-101 achieved the fast-acting antidepressant
effects of ketamine – but AV-101 greatly differed in that it did not induce the
adverse and psychosis-like side effects associated with ketamine and other
classic NMDAR channel blockers.
In mid-February 2015, VistaGen broke ground and entered into
a Cooperative Research and Development Agreement (CRADA) with the U.S. National
Institute of Mental Health (NIMH), part of the NIH. Per the CRADA, VistaGen and
the NIMH will collaborate on an NIH-sponsored phase 2 clinical study of AV-101
to evaluate the efficacy and safety of the drug candidate in subjects with major
depressive disorder (MDD). The study is expected to begin in the first half of
this year.
VistaGen isn’t leaving much room for mistakes. The company
recently welcomed key opinion leader Gerard Sanacora PhD, MD, professor of
Psychiatry at the Yale School of Medicine and director of the Yale Depression
Research Program, to its Clinical and Scientific Advisory Board. Dr. Sanacora
will collaborate with VistaGen to focus on phase 2 and phase 3 clinical
development of AV-101 in MDD.
In addition to depression, VistaGen is also pursuing
applications of AV-101 for other indications involving the central nervous
system, including chronic neuropathic pain, epilepsy and neurodegenerative
diseases such as Parkinson’s and Huntington’s disease. The WHO’s invigorated push
for a new approach to depression treatment, however, along with the NIH’s
willingness to fully-sponsor the impending Phase 2 clinical study, validates
VistaGen’s primary focus of advancing AV-101’s potential as a revolutionary
antidepressant for the millions globally who are inadequately served by current
medications.
For more information, visit www.vistagen.com
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