VistaGen Therapeutics (VTGN) Expands European Patent Protection for AV-101 for Treatment of Depression and Dyskinesia associated with Levodopa Therapy for Parkinson's Disease

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, today announced that the European Patent Office (EPO) has granted the Company a second patent for therapeutic uses of AV-101, its oral NMDA (N-methyl-D-aspartate) receptor glycine site antagonist. The new patent expands the set of claims relating to treatment of depression and dyskinesia (involuntary or diminished voluntary muscle movements) associated with levodopa therapy for Parkinson's disease. The patent will be in effect until at least 2034.

AV-101 (4-Cl-KYN) belongs to a new generation of investigational medicines in neuropsychiatry and neurology known as NMDA receptor modulators. The NMDA receptor is a pivotal receptor in the brain and its abnormal function is associated with numerous CNS diseases and disorders. AV-101 is in Phase 2 clinical development in the United States, initially for treatment of Major Depressive Disorder (MDD). Among VistaGen's key objectives for AV-101 in MDD is to replace atypical antipsychotics in the current MDD drug treatment paradigm and to redefine the standard of care for individuals who are unable to reduce symptoms of depression with their current oral antidepressant alone. VistaGen recently completed patient dosing in the ELEVATE study, its 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 their current oral antidepressant therapy. The Company remains on track to report top line results of the ELEVATE study before the end of 2019.

In previously announced positive preclinical studies of the effects of AV-101 in a widely-used non-human primate model for reproducing motor complications of Parkinson's disease (PD) and dyskinesia observed in PD patients treated with levodopa, AV-101 significantly (p = 0.01) reduced levodopa-induced dyskinesia without affecting the timing, extent, or duration of the antiparkinsonian benefits of levodopa. AV-101's therapeutic effects were similar to those generally observed with amantadine therapy, but AV-101 did not cause adverse effects experienced with amantadine.

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