Source: VistaGen Therapeutics, Inc.
Former Clinical Lead for Neuropsychiatry at Teva Pharmaceuticals to lead clinical development of AV-101 in major depressive disorder (MDD) and additional CNS pipeline programs
VistaGen Therapeutics, Inc. (NASDAQ: VTGN) (VistaGen or the Company), a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative product candidates for patients with diseases and disorders involving the central nervous system (CNS), today announced it has appointed Mark A. Smith, M.D., Ph.D., as Chief Medical Officer.
"Throughout 2016 we have made
great strides in positioning VistaGen for a transformational year,
specifically with the addition of preeminent members to our Clinical and Regulatory Advisory Board, the completion of our recently announced $10.9 million financing led by healthcare focused fundamental investors, and our graduation to NASDAQ last month," commented Shawn Singh, Chief Executive Officer of the Company.
"The next critical element to achieving
our vision is expanding and strengthening our management team to include
an industry veteran with extensive CNS clinical development expertise
and a broad network. We are incredibly pleased to have attracted Dr.
Smith to our team as Chief Medical Officer at such a pivotal time for
the Company. His contributions and leadership, both immediately and
long term, will be invaluable as we continue to advance our lead CNS
product candidate, AV-101, through our ongoing Phase 2a study in MDD and
launch our potentially pivotal Phase 2b study in MDD later this year,"
added Mr. Singh.
Dr. Smith is a research
psychiatrist with more than 20 years of experience in basic research and
CNS drug development from the lab bench through clinical proof of
concept studies. He has been a successful project leader in both
discovery and development resulting in approximately 20 investigational
new drugs (INDs). Dr. Smith has directed clinical trials aimed at
depression, bipolar disorder, anxiety, schizophrenia, Alzheimer's, ADHD
and agitation in Phase 1 through Phase 2b and has vast knowledge and
expertise in drug discovery and development, translational neuroscience,
clinical trial design and regulatory interactions.
"VistaGen has tremendous
potential to transform the treatment paradigm in major depressive
disorder and significantly improve the standard of care where there
truly remains an unmet need. AV-101 is a promising CNS drug candidate
opportunity in MDD and other CNS diseases and is fundamentally
differentiated from currently approved treatment alternatives,
representing a new generation of antidepressants with faster
antidepressant effects without the undesired side effects that are far
too common with existing treatments," stated Dr. Smith. "I am honored
and thrilled to be joining the VistaGen team at such an important time
for the Company alongside leading experts in the field, and I believe
that with AV-101, we have the potential to positively change the lives
of those who suffer from depression and other CNS diseases," concluded
Dr. Smith.
Prior to joining VistaGen,
Dr. Smith served as the Clinical Lead for Neuropsychiatry at Teva
Pharmaceuticals, where he was accountable for the strategy and clinical
development of neuropsychiatric drugs through all phases of development
with a focus on schizophrenia, sleep disorders and agitation.
Previously, Dr. Smith held a range of director positions including
Executive Director of Clinical Development at AstraZeneca Pharmaceutical
Company where he led the early development of several novel chemical
entities targeting treatment-resistant depression, anxiety and
schizophrenia. Dr. Smith has also held positions as Senior Director of
Experimental Medicine of Global Clinical Development and Innovation at
Shire Pharmaceuticals and served as Senior Investigator and Principal
Research Scientist of CNS Diseases at DuPont Pharmaceuticals. Prior to
joining the pharmaceutical industry, he served as a Senior Staff
Scientist of the Biological Psychiatry Branch and Senior Staff Fellow of
the Clinical Neuroendocrinology Branch at the U.S. National Institute
of Mental Health (NIMH).
Dr. Smith received his Bachelors degree and Master of Science from Yale University, his Doctor of Medicine and Doctor of Philosophy in Physiology and Pharmacology from the University of California, San Diego, and completed his residency in the Department of Psychiatry at Duke University Medical Center.
VistaGen's lead oral prodrug candidate, AV-101,
is currently being evaluated in an ongoing NIMH-sponsored Phase 2a
clinical study for the treatment of major depressive disorder (MDD).
The Company expects to report topline data from the Phase 2a clinical
study in the second quarter of 2017 and is preparing to advance AV-101
into a Phase 2b MDD study in the fourth quarter of this year.
About AV-101
AV-101 (L-4-chlorokyurenine
or 4-CI-KYN) is an orally-available prodrug candidate, currently in
Phase 2 development, initially for the adjunctive treatment of major
depressive disorder (MDD) in patients with an inadequate response to
standard antidepressants. AV-101 has broad potential utility in other
CNS diseases and disorders, including chronic neuropathic pain, epilepsy
and neurodegenerative diseases, such as Parkinson's disease and
Huntington's disease. AV-101 is orally available, rapidly absorbed
through the gut, and then actively transported across the blood-brain
barrier. Astrocytes in the brain rapidly convert AV‑101 into its active
metabolite, 7-chlorokynurenic acid (7-Cl-KYNA), a well-characterized,
potent and selective antagonist of N-methyl-D-aspartate (NMDA)
receptors, acting by blocking the glycine-binding co-agonist site of the
NMDA receptor. AV-101 is a member of a new generation of fast-acting
glutamatergic drug candidates in development for treatment of MDD. These
fast-acting drug candidates act through the AMPA receptor pathway
increasing the production of nerve connections in the brain - often
referred to as "synaptogenesis." The increase in synaptogenesis is
thought to be the mechanism by which these new generation fast–acting
antidepressant drug candidates provide therapeutic benefit for
depression.
About VistaGen
VistaGen Therapeutics, Inc.
is a clinical-stage biopharmaceutical company dedicated to developing
and commercializing innovative product candidates for patients with
diseases and disorders involving the CNS. VistaGen's lead product
candidate, AV-101, is a next generation, orally available prodrug in
Phase 2 development, initially for the adjunctive treatment of MDD in
patients with an inadequate response to standard antidepressants. AV-101
is currently being evaluated in an ongoing Phase 2a clinical study
being conducted by Principal Investigator, Dr. Carlos Zarate,
Chief, Section on the Neurobiology and Treatment of Mood Disorders and
Chief of Experimental Therapeutics and Pathophysiology Branch at the
NIMH, and fully funded by the NIMH.
