Could VistaGen's AV101 Be The Next Abilify?

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I've been following VistaGen Therapeutics (NASDAQ: VTGN) for several months now. The California-based biotech is developing AV101, a glycine B (GlyB) receptor antagonist that negatively modulates the N-Methyl-D-aspartic acid (NMDA) receptor. AV-101 is an oral prodrug candidate that has demonstrated impressive antidepressant effects and safety in preclinical and Phase 1 studies.

The mechanism of action is similar to ketamine, which means it might also prove useful in other psychiatric disorders such as bipolar depression, suicidal ideation, obsessive-compulsive disorder, and anxiety. AV101 may induce synaptogenesis, which might hold utility to treat neurodegenerative diseases like Huntington's disease or in patients following a traumatic brain injury. The drug is also unlikely to be abused, which opens the potential for lack of DEA scheduling and expanded patient populations like adolescents and the elderly. 

In short, I think AV101 has tremendous potential. It reminds me of Abilify® (aripiprazole), one of the most successful drugs of all time. Aripiprazole was developed by Otsuka Pharmaceuticals Co. Ltd of Japan and was co-promoted in the U.S. for over a decade by Bristol-Myers Squibb. The agreement expired in 2012, at which time Otsuka regained full rights. Sales peaked at nearly $9.5 billion worldwide in 2013, nearly $7 billion of which was in the U.S. The patent has since expired and the drug is now widely available as a generic. 

For the purpose of this article, I thought I'd look at the potential for AV101 to be "the next Abilify", or at the very least, be used similarly to Abilify as an adjunct therapy for patients failing first- and second-generation antidepressants. That market alone is blockbuster in size. Adding on some of the additional indications, like bipolar depression, acute suicide prevention, or anxiety, could put AV101 in the same category as Abilify as one incredibly successful CNS drug.

Abilify - The Most Successful CNS Drug Of All Time

Abilify® is the most successful CNS pharmaceutical product of all-time. Sales peaked at $9.5 billion in 2013; and, to date, it ranks as the fifth best-selling drug ever by dollar volume (1). That's darn impressive for a drug whose inventors admit are unsure how it even works!

Regardless of the exact mechanism, Abilify is approved for some incredibly large indications. There are nearly 45 million American's with mental illness (2), and the Abilify label hits several of the largest populations, including schizophrenia, bipolar mania, depression, and agitation. 

Abilify was first approved in November 2002 for schizophrenia. Of particular interest to shareholders of VistaGen Therapeutics is the third approval, which came five years later in November 2007 for the adjunctive treatment of major depressive disorder (MDD). This is the initial target population for AV101 in the current Phase 2a clinical trial being conducted by researchers at the National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH), under the principal investigation of Dr. Carlos A. Zarate, MD. Only in this study, the NIMH is studying AV101 as a monotherapy.

Either as a monotherapy or an adjunct to ineffective standard-of-care, treatment-resistant depression (TRD) is an enormous market opportunity. According to data from the NIMH and CDC, roughly 7% of the U.S. population over the age of 12 years suffer from depression. Based on 2015 Census data, this equates to approximately 20 million individuals. NIMH research shows about half of these patients receive pharmacotherapy. Unfortunately, results of a 4,000-patient NIMH-sponsored trial in 2006 (STAR*D) showed only 36.8% achieve remission on first-line (generic) antidepressants.

Nearly two-thirds of these patients will try alternative antidepressants, which may include switching to a different selective serotonin reuptake inhibitor (SSRI) or trying a serotonin-norepinephrine reuptake inhibitor (SNRI), a tricyclic antidepressant (TCA), or a monoamine oxidase inhibitor (MAOI). Even with all these alternatives, the overall cumulative remission rate is only 67%. This means one-third of subjects with depression, a target of around 3-4 million patients in the U.S. each year, are in desperate need of an alternative treatment option.

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