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VistaGen Therapeutics Announces Last Patient Completes Dosing in the ELEVATE Phase 2 Clinical Study of AV-101 for Major Depressive Disorder
SOUTH SAN FRANCISCO, Calif., Oct. 8, 2019 /PRNewswire/ -- VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., Oct. 8, 2019 /PRNewswire/ -- VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, announced today that 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.\n\n \nAbout AV-101 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.\nAbout the ELEVATE Study Among VistaGen's key objectives for AV-101 in MDD is to replace atypical antipsychotics in the current MDD drug treatment paradigm and redefine the standard of care for individuals who are unable to reduce their symptoms of depression with their current oral antidepressant alone. The ELEVATE study is VistaGen's U.S. multi-center, randomized, double-blind, placebo-controlled Phase 2 clinical study to evaluate the efficacy and safety of adjunctive use of AV-101 in adult MDD patients who have an inadequate response to standard FDA-approved oral antidepressant therapy. VistaGen achieved target enrollment (n = 180) in the ELEVATE study in August 2019. ...