Depression
affects nearly 7% of all adults in the U.S. and over 350M people worldwide
according to the World Health Organization, and it is a major contributor to overall
disease statistics. GBI Research forecasts the global antidepressant market as
growing to around $13.4B by 2018 with a CAGR of approximately 1.8%, even though
the primary market component, serotonin re-uptake inhibitors (SSRIs), has
continued to produce red flags like ill-served patients and a variety of
dangerous side effects.
The
FDA-approved anaesthetic ketamine is currently used for starting and
maintaining anesthesia, with the chief applications being to induce sedation
during intensive care or as a serious pain killer. However, ketamine has also
more recently been shown to have significant effect as a fast-acting
antidepressant in depression patients that don’t respond well to the typical
depression medicine available on the market today, such as Prozac, which mostly
target monoamine neurotransmitters. Pharmacologically classified as an NMDA
(N-methyl-D-aspartate) receptor antagonist, ketamine induces a trance-like
state and, in addition to pain relief and sedation, causes memory loss. Ketamine
is classified as a dissociative agent alongside other drugs in its class, like
PCP (phencyclidine), with side psychotomimetic effects like confusion, seeing
flashing lights and bright color, things that make it popular as a club drug of
abuse. The clinical and therapeutic emergence of ketamine in major depressive
disorder (MDD) has naturally been significantly slowed down, despite its
efficacy in placebo-controlled studies at the NIH, due to these acute
psychosis-like side effects (and the potential for abuse, despite having to be
administered intravenously), opening up a massive opportunity for a new
generation of safe and effective, fast-acting drugs giving the benefits of
ketamine while minimizing or eliminating these psychotomimetic side effects.
The rush
is now officially on to bring such fast-acting antidepressant agents to market,
but to gain widespread approval and clinical acceptance, such agents would
ideally need to have comparably robust efficacy and rapidity of onset to
intravenously (IV) administered ketamine, according to the Global Therapeutic
Head of Neuroscience at Johnson & Johnson (NYSE:JNJ), Husseini K. Manji,
MD, FRCPC. Dr. Manji has also noted that to truly gain widespread acceptance,
such agents really need vital characteristics that further distinguish them
from ketamine, like oral availability and a toxicology profile that would make
the agent viable for daily or even chronic use.
One such
promising new generation agent, GLYX-13, is an IV-administered partial NMDA
receptor agonist being developed by a private company, Naurex, Inc. which
raised $18M during its launch of Phase 2 efficacy testing for GLYX-13 back in
2011, and that was without any prior clinical efficacy data. To date, based
mostly on the potential of GLYX-13, which is currently Phase 3-ready, Naurex
has raised over $160M from a broad array of sector heavy-hitters, including
Baxter Ventures, the venture capital arm of Baxter International (NYSE:BAX).
Naurex’s latest raise brought in $80M this December 3, largely due to positive
Phase 2 data showing robust and sustained antidepressant effect in major
depressive disorder patients, again with giants like Baxter and Genesys
(NSE:GENESYS) on board.
Another
promising new generation antidepressant agent, currently entering Phase 2
development, the same pipeline stage as GLYX-13 was in when Naurex raised that
first $18M chunk of their development war chest, is AV-101 from VistaGen
Therapeutics (OTCQB: VSTA). VistaGen’s share price is highly accessible to
investors and the company is currently poised to launch an important Phase 2
clinical efficacy study of AV-101 in early 2015. The company is planning to
collaborate with the National Institute of Mental Health (NIMH) under a
Cooperative Research and Development Agreement (CRADA) expected to provide NIH
sponsorship of the study.
AV-101, a
prodrug which is rapidly and enzymatically converted into the established and
highly potent NMDAR antagonist, 7-chlorokynurenic acid (7-Cl-KYNA), after
crossing the blood-brain barrier, is novel, orally available (in a capsule),
non-sedating, and non-hallucinogenic, with no signs of the schizophrenia-like
side effects associated with other NMDA channel blockers, such as ketamine.
VistaGen’s focus on the glycine binding site (GlyB) within the NMDAR could
prove to be one of the best approaches in the new generation antidepressant
space to date, potentially offering compelling advantages over competitors like
oral-availability and a highly selective method of action.
VistaGen
also has an ace up their sleeve, a highly-respected NIH physician with
considerable clinical experience using ketamine in major depression, Dr. Carlos
Zarate, Chief of the Experimental Therapeutics & Pathophysiology Branch
(ETPB) and Section on the Neurobiology and Treatment of Mood Disorders at the
NIMH. Dr. Zarate will be conducting the NIH-sponsored Phase 2 efficacy study of
AV-101 for major depression early next year. They should have the CRADA
hammered out sometime early next month. Savvy investors will want to keep an
ear to the ground for developments on AV-101, as this candidate could emerge as
one of the leading new generation antidepressants, with therapeutic potential
in a variety of central nervous system (CNS) disorders as well, including
chronic neuropathic pain, epilepsy and even neurodegenerative diseases like
Parkinson’s disease and Huntington’s disease.
For more
information on VistaGen Therapeutics, visit: www.vistagen.com
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