VistaGen (OTCQB: VSTA) First Patient Dosed in NIH-Sponsored P2A Study of Orally Available AV-101 in MDD - BUY

November 3, 2015 8:30am

The study is being fully funded by the U.S. NIH, and is being conducted at the U.S. National Institutes of Mental Health (NIMH. 

VistaGen Therapeutics’ (OTCQB: VSTA) first patient has been dosed in a P2A study of its orally available AV-101 in adult patients with treatment-resistant Major Depressive Disorder (MDD).

• VSTA received clearance from the U.S. FDA and the NIH to initiate the study in July 2015, after entering into a Cooperative Research and Development Agreement (CRADA) with the NIMH in February 2015. 

The single-site (NIH) P2A study, expected to enroll between 24 and 28 adult patients with treatment resistant MDD, is a randomized, double-blind, placebo-controlled, crossover trial designed to evaluate the efficacy and safety of a single oral dose of AV-101 administered once daily for 14 days.

The Bottom Line: The study is being fully funded by the U.S. NIH, and conducted at the U.S. National Institutes of Mental Health (NIMH - an important factor with a milestone in advancing AV-101 clinical development program.  AV-101’s has a differentiated mechanism of action, oral availability, strong pre-clinical efficacy and excellent clinical safety. 

Efficacy and safety of the patient data will be evaluated using the standard Hamilton Depression Rating Scale (HDRS-17) and other widely-accepted measures of mood and depression. Top-line data is expected in the first half of 2017.

VSTA closed  at $7.49, flat on 11/2 and with no volume - BUY

AV-101 is an orally available, prodrug candidate that readily gains access to the central nervous system (CNS) after systemic administration and is rapidly converted in the brain by astrocytes into its active metabolite, 7-chlorokynurenic acid (7-Cl-KYNA), a well-characterized, potent, and highly-selective antagonist of the glycine-binding co-agonist (GlyB) site of the N-methyl-D-aspartate receptor (NMDAR). Current evidence suggests that AV-101's antagonism of NMDAR signaling may provide fast-acting antidepressant effects in the treatment of MDD. Preclinical peer-reviewed data published in the October 2015 Journal of Pharmacology and Experimental Therapeutics showed rapid, dose-dependent and persistent ketamine-like antidepressant effects, without the negative side effects seen with ketamine, and other channel-blocking NMDAR antagonists. In addition, as confirmed in two Phase 1 clinical studies, using AV-101 to target the GlyB site of the NMDAR may bypass potential adverse effects that occur with ketamine, while activating similar therapeutic pathways resulting in the "glutamate surge" that has been associated with increased neurogenesis and the rapid-acting antidepressant effects of ketamine observed in previous clinical studies.

While most people will experience episodic depressed mood at multiple points during their life, MDD is different. MDD is the chronic, pervasive feeling of utter unhappiness, hopelessness and suffering, which impairs daily functioning. Symptoms of MDD include diminished pleasure in activities, changes in appetite that result in weight changes, insomnia or oversleeping, psychomotor agitation, loss of energy or increased fatigue, feelings of worthlessness or inappropriate guilt, difficulty thinking, concentrating or making decisions, and thoughts of death and attempts at suicide. Suicide is estimated to be the cause of death in up to 15% of individuals with MDD. MDD is one of the most common mental disorders in the United States. According to the NIMH, about 6.7% of U.S adults experience MDD each year.