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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