According to VistaGen, the issuance of US Patent No. 9,993,453, which relates to AV-101’s therapeutic uses to treat depression, and US Patent No. 9,993,450, which covers AV-101’s oral dosage formulations, marks a “fundamental advancement” in its plan to secure commercial exclusivity.
AV-101 is an oral N-methyl-D-aspartate receptor glycine B (NMDA receptor GlyB) antagonist in Phase II clinical development to treat multiple central nervous system (CNS) indications with unmet medical need.
As an NMDA receptor modulator, the candidate has the potential to deliver ketamine-like antidepressant effects, CEO Shawn Singh told us.
In addition, AV-101 could deliver these effects “without the need for inconvenient administration in a medical setting, and without causing psychological or other negative side effects and safety concerns often associated with ketamine therapy,” said Singh.
“Current evidence suggests that AV-101’s modulation of NMDA receptor signaling may provide faster-acting antidepressant effects in the treatment of MDD than current FDA-approved antidepressants,” he added.
Upon completion of the Phase II trial, VistaGen intends to develop AV-101 internally through Phase III and an eventual submission of a new drug application (NDA) to the FDA.
“If its initial MDD-related NDA is approved by the FDA, the company may pursue strategic partnerships to maximise the commercial potential of AV-101 for…additional MDD indications and multiple other CNS indications,” we were told.
VistaGen has been looking to secure patents that relate to a variety of therapeutic areas. In August 2017, the clinical-stage firm announced receipt of a notice of allowance from the USPTO related to a stem cell production patent it said could be used in autoimmune and cancer treatments.