According to the National Institute of Mental Health (NIMH),
major depression is one of the most common mental disorders in the United
States. In 2013, an estimated 15.7 million individuals aged 18 or over –
roughly 6.7 percent of all U.S. adults – had at least one major depressive
episode. For these individuals, finding relief can be difficult. The American
Academy of Family Physicians reports that up to two-thirds of all patients
diagnosed with major unipolar depression will not respond to the first medication
prescribed. If the second form of treatment also fails to produce a significant
clinical improvement, the patient’s depression may be considered resistant to
treatment. At this point, individuals have traditionally had extremely limited
options for conquering this debilitating condition.
VistaGen Therapeutics, Inc. (OTCQB: VSTA), through the
development of AV-101, is addressing this underserved indication. Earlier
today, the company announced that it has taken a major step toward the eventual
commercialization of its innovative drug candidate by dosing the first patient
in its ongoing phase IIa study of AV-101 for treatment-resistant major
depressive disorder (MDD). The study, which is being funded by the NIMH, is
expected to enroll between 24 and 28 adult patients in order to evaluate the
efficacy and safety of a single oral dose of AV-101 administered once daily for
two weeks.
“We are pleased to have achieved this important milestone,
notably advancing our AV-101 clinical development program, and we look forward
to working closely with the esteemed leadership team at the NIMH,” Shawn Singh,
chief executive officer of VistaGen, stated in a news release. “We believe that
AV-101’s differentiated mechanism of action, oral availability, strong preclinical
efficacy and excellent clinical safety profile support AV-101 as a potentially
transformative treatment for millions of patients with MDD who are inadequately
served by standard antidepressant therapies.”
In previous clinical testing, AV-101 has exhibited a host of
sustained anti-depressant effects that exceed the effectiveness of currently
available medications in the multi-billion dollar global antidepressant market
– including serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine
reuptake inhibitors (SNRIs). While SSRIs and SNRIs must be taken for several
weeks before patients experience significant therapeutic benefits, AV-101 has
demonstrated robust and rapid antidepressant effects similar to the benefits of
ketamine without the high potential for abuse and psychosis-like behavioral
side effects.
With its phase IIa study now underway, VistaGen expects
top-line data in the first half of 2017. For prospective shareholders, the
company’s progress toward the commercialization of its groundbreaking drug
candidate makes it an intriguing investment opportunity in the coming months.
Look for VistaGen to continue to benefit from its collaboration with the NIMH
as it progresses toward a potentially transformative advancement in the
treatment of MDD.
For more information on the company, visit www.vistagen.com
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