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VistaGen Therapeutics Achieves Target Patient Enrollment in the ELEVATE Study of AV-101 as an Adjunctive Treatment for Major Depressive Disorder
Company on Track to Report Topline Data Before Year EndSOUTH SAN FRANCISCO, CA / ACCESSWIRE / August 15, 2019 / VistaGen Therapeutics (NASDAQ:VTGN), a
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"Company on Track to Report Topline Data Before Year EndSOUTH SAN FRANCISCO, CA / ACCESSWIRE / August 15, 2019 / 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 Company has achieved completion of target patient enrollment (n = 180) in its Phase 2 ELEVATE clinical trial. ELEVATE is a multi-center, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of AV-101, VistaGen’s novel, oral NMDA (N-methyl-D-aspartate) receptor glycine site antagonist, as an adjunctive treatment (together with an FDA-approved oral antidepressant (AD)) for major depressive disorder (MDD) in adult patients with an inadequate therapeutic response to their current AD.VistaGen expects to report topline results from the Phase 2 ELEVATE study before the year end 2019.“We are very encouraged to reach this important milestone in our Phase 2 development program for AV-101 in MDD. Achieving target patient enrollment puts us one step closer to redefining the standard of care for a large and growing number of individuals who are unable to reduce their symptoms of depression with their current antidepressant alone,” said Shawn Singh, Chief Executive Officer, VistaGen. “We look forward to completing the ELEVATE study in the near term and reporting topline data by year end.”About AV-101AV-101 (4-Cl-KYN) belongs to a new generation of investigational medicines in neuropsychiatry and neurology known as NMDA (N-methyl-D-aspartate) glutamate receptor modulators. The NMDA receptor is a pivotal receptor in the brain and abnormal NMDA function is associated with multiple CNS diseases and disorders, including chronic neuropathic pain, epilepsy, MDD, levodopa-induced dyskinesia (LID) and many others. AV-101 is an oral prodrug of 7-Cl-KYNA which binds uniquely at the glycine 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 meet high unmet patient needs. VistaGen is currently focused on potential development of AV-101 for MDD, neuropathic pain, suicidal ideation and dyskinesia associated with levodopa treatment fo...