VistaGen Therapeutics (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-101

AV-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 for Parkinson’s disease. The FDA has granted Fast Track designation for development of AV-101 as both a potentialadjunctive treatment for MDD and as a non-opioid treatment for neuropathic pain.

About ELEVATE
Among VistaGen’s 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 antidepressant alone. The ELEVATE study is an ongoing 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 antidepressant therapy, either a selective serotonin reuptake inhibitor (SSRI), a serotonin norepinephrine reuptake inhibitor (SNRI), or bupropion. The primary endpoint of the study is the change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS-10) total score.

About Major Depressive Disorder (MDD)
MDD is a serious neurobiologically-based mood disorder, affecting approximately 16 million adults in the U.S., according to the NIMH. 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 worldwide.

About VistaGen

VistaGen Therapeutics is a clinical-stage biopharmaceutical company developing new generation medicines for CNS diseases and disorders where current treatments are inadequate, resulting in high unmet need. VistaGen’s pipeline includes three differentiated, clinical-stage CNS drug candidates, AV-101, PH10 and PH94B, each with an exceptional safety profile in all clinical studies to date and therapeutic potential in multiple large and growing CNS markets. For more information, please visitwww.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.