Potential to Address Major U.S. and Global
Need
It’s one of the single most sought-after drugs
in the medical industry, and biotechnology company VistaGen Therapeutics may
have it. What is so desperately needed is a drug able to treat a disease that
afflicts tens of millions of people in the U.S., and hundreds of millions
globally. The disease is MDD (Major Depressive Disorder), a crippling form of
depression that is not effectively treated by existing medications. It is now
recognized as a disease that seriously undermines economies and society as a
whole, contributing to hundreds of thousands of deaths worldwide each year. The
recent death of actor and comedian Robin Williams has shed a public light on
the gravity of individual depression, but researchers know that it affects as
many as one out of 20 households. They also know the significant issues with
standard treatments for MDD.
Current Drugs Too Slow or With Side Effects
Traditional FDA-approved drugs currently used
to treat depression are very slow acting, a consequence of the way they operate
in the brain. It can take weeks or even months to achieve the intended benefit
of these antidepressants, time that patients experiencing an MDD crisis often
don’t have. The lack of noticeable and timely results with such treatments can
easily discourage people with MDD from continuing with their antidepressant
medications. In desperation a patient can slide from one drug to another until
they feel they’ve run out of options, potentially with fatal results.
So anxious is the medical establishment for an
effective quick-acting anti-depressant that ketamine, a multi-purpose pain
killer and anesthetic, has been re-purposed by certain physicians as an
anti-depressant, primarily because of its ability to deliver rapid, robust
antidepressant effects in MDD patients. An article in Scientific American
(http://dtn.fm/gkE0) talked about how the ketamine’s promise has ignited
excitement among clinicians and neuroscientists, in spite of its associated
adverse effects, pointing out that “a person taking ketamine may experience
altered physical, spatial and temporal states; larger quantities may induce
hallucinations and dissolution of the self”. Over and above what an article in
Nature Reviews (http://dtn.fm/4LjI) called “psychosis-like side effects”,
another major problem with ketamine is that it must be given intravenously.
Forcing patients to get frequent infusions to stave off depression is nobody’s
idea of an optimum solution, but it underscores the serious, unmet medical need
in this area.
New Drug May Be Perfect Storm
Amidst all of this has come a highly
innovative new approach from California-based VistaGen Therapeutics, a
biopharmaceutical company known primarily for its stem cell technology.
VistaGen’s novel, orally available MDD drug candidate AV-101 is ready for Phase
2 clinical development in the U.S. and is starting to look like a very big
deal, because it offers the promise of being an antidepressant that is both
powerful and quick-acting, while at the same time causing none of the
mind-bending side effects of ketamine. The drug operates in a different way
than the other FDA-approved antidepressant drugs, providing a much more
moderated effect while still getting the job done. NIH sponsored Phase 1
studies of AV-101 have already shown it to be a remarkably safe and
well-tolerated compound. Perhaps even more notable is the fact that AV-101 can
be taken orally, with no need for regular injections or IV administration. It’s
an almost ideal combination of properties, with a multi-billion dollar market
on the table.
From a technical standpoint, AV-101 (4-Cl-KYN)
is an orally-available, non-sedating, non-hallucinogenic prodrug (precursor
drug) that is rapidly and enzymatically converted to its active metabolite,
7-chlorokynurenic acid (7-Cl-KYNA), one of the most well-characterized, potent,
and selective synthetic blockers of N-methyl-D-aspartate (NMDA) receptors at
the glycine-coagonist (GlyB) site. Although the pathophysiology of depression
has been linked to monoaminergic mechanisms for decades, compelling evidence
now suggests a key role of the glutamatergic system in mood disorders and
favors the idea that AV-101’s targeted antagonism of the glycineB site of the
NMDA receptor can provide rapid, robust antidepressant effects in treatment of
MDD similar to ketamine, but without ketamine’s serious side effects.
VistaGen is currently preparing for a Phase 2
MDD study in early 2015, so keep an eye open for announcements.
In addition to MDD, AV-101 is now also being
seen as a potential treatment for other diseases involving the central nervous
system, including epilepsy, chronic neuropathic pain, and neurodegenerative
disorders such as Parkinson’s disease.
For additional information, visit the
company’s website at www.vistagen.com
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