VistaGen Therapeutics announced the last patient has completed dosing in the ELEVATE Phase 2 clinical study of AV-101, the Company's novel, oral NMDA (N-methyl-D-aspartate) receptor glycine site antagonist, as an adjunctive (add-on) treatment with an FDA-approved oral antidepressant for major depressive disorder (MDD). The Company remains on track to report top line results of the ELEVATE study before the end of 2019.
AV-101 (4-Cl-KYN) belongs to a new generation of investigational medicines in neuropsychiatry and neurology known as NMDA glutamate receptor modulators. The NMDA receptor is a pivotal receptor in the brain and abnormal NMDA function is associated with numerous CNS diseases and disorders. AV-101 is an oral prodrug of 7-Cl-KYNA, a potent and selective full antagonist of the glycine coagonist site of the NMDA receptor. With its exceptional safety profile in all studies to date, AV-101 has potential to be a new at-home treatment for multiple large market CNS indications where current treatments are inadequate to satisfy high unmet patient needs. VistaGen is currently focused on AV-101's potential to treat depression, dyskinesia associated with levodopa therapy for Parkinson's disease, epilepsy, neuropathic pain and suicidal ideation. The FDA has granted Fast Track designation for development of AV-101 as a potential adjunctive treatment for MDD and as a non-opioid treatment for neuropathic pain.
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MDD is a serious neurobiologically-based mood disorder, affecting approximately 17.3 million adults in the U.S., or 7.1% of the U.S. adult population, according to the U.S. National Institute of Mental Health. Individuals diagnosed with MDD exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities, for more than a two-week period, as well as impaired social, occupational, educational or other important functioning which has a negative impact on their quality of life. Globally, MDD affects nearly 300 million people of all ages and is the leading cause of disability according to the World Health Organization.