VistaGen Therapeutics has obtained US Food and Drug Administration (FDA) clearance for its investigational new drug (IND) application of AV-101 to treat dyskinesia in Parkinson’s disease patients.

AV-101 is an antagonist of N-methyl-D-aspartate receptor (NMDAR) glycine site. NMDAR is a key receptor in the brain and abnormality in the receptor’s function leads to various CNS diseases.

The drug candidate is a prodrug of 7-chloro-kynurenic acid (7-Cl-KYNA). It is expected to offer an at-home, non-sedating therapy option for CNS indications that do not respond adequately to existing treatments.

AV-101 currently has FDA fast-track designation for the adjunctive treatment of major depressive disorder (MDD) and as a non-opioid treatment for neuropathic pain.

The latest FDA clearance allows the company to initiate Phase II clinical development of the drug candidate for dyskinesia in Parkinson’s patients on levodopa-based therapy.

VistaGen Therapeutics CEO Shawn Singh said: “In all clinical studies to date, AV-101 has not been associated with any psychotomimetic side effects or drug-related serious adverse events.

“With its exceptional safety profile, recently successful preclinical studies in the leading primate model for LID, and the successful Phase Ib NMDAR target engagement clinical study conducted by Baylor College of Medicine in healthy volunteer US military Veterans, we are excited by AV-101’s potential as a novel therapy for levodopa-induced dyskinesia.”

In November last year, VistaGen reported that AV-101 did not meet the primary endpoint in a Phase II trial of patients with MDD.

Data showed no difference in the Montgomery-Åsberg Depression Rating Scale (MADRS-10) total score between AV-101 and placebo groups. AV-101 was well-tolerated without any psychotomimetic side effects or serious adverse events.

Apart from levodopa-induced dyskinesia and MDD, the drug candidate is being studied for the treatment of epilepsy, neuropathic pain, and suicidal ideation.