Investigators will move forward with a phase 2 study testing AV-101 as a potential treatment for patients with Parkinson disease receiving levodopa-based therapy.
The US Food and Drug Administration (FDA) has awarded an Investigational New Drug (IND) application for AV-101, a NMDAR (N-methyl-D-aspartate receptor) glycine site antagonist, as a potential treatment of dyskinesia in patients with Parkinson disease receiving levodopa-based therapy.
The IND clearance allows VistaGen Therapeutics to move forward with a phase 2 clinical development program on this indication.
VistaGen also received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for a US Patent Application 16/003,816 related to therapeutic use of AV-101 for treatment of dyskinesia induced by the administration of levodopa. If issued, the patent will be in effect until at least 2034.
Investigators presented preclinical data during the 7th International Conference on Parkinson’s and Movement Disorders in London showing that the treatment reproduced motor complications of the disease in non-human primate models, including dyskinesia observed in Parkinson disease patients treated with levodopa.
In the MPTP primate model, the antidyskinetic activity of the new treatment compared favorably with prior observations with amantadine in parkinsonian monkeys.
AV-101 was favorable to amantadine, which comes with known side effects.
In the study, the new drug’s efficacy against LID was measured through behavioral scores on a dyskinesia scale, as well as a parkinsonian disability scale to measure levodopa antiparkinsonian efficacy.
The study demonstrated that AV-101 significantly (P = .01) reduced LID without affecting the timing, extent, or duration of the therapeutic benefits of levodopa.
“Current drug treatment options for levodopa-induced dyskinesia, or LID, may cause serious side effects, including hallucinations and sedation,” Shawn Singh, Chief Executive Officer of VistaGen, said in a statement. “In all clinical studies to date, AV-101 has not been associated with any psychotomimetic side effects or drug-related serious adverse events.”