Pipeline

AV-101 (L-4-chlorokynurenine) Pipeline

AV-101 Mechanism of Action

AV-101's Active Metabolite (7-Cl-KYNA) Does Not Block NMDA Receptor Activity; It Inhibits It

In peer-reviewed and published preclinical studies, AV-101 demonstrated the robust antidepressant-like activity of the NMDA receptor antagonist ketamine hydrochloride, an FDA-approved anesthetic, including low dose ketamine's rapid onset and long duration of antidepressant effects, but without any of ketamine's psychotomimetic and hallucinogenic side effects. In two NIH-funded randomized, double-blind, placebo-controlled Phase 1 safety studies, AV-101 was safe, well-tolerated and not associated with any drug-related severe adverse events. There were no signs of ketamine-like side effects, such as sedation, hallucinations or schizophrenia-like side effects which are often associated with ketamine and other ion channel-blocking NMDA receptor antagonists.

AV-101 is in Phase 2 clinical development in the United States, initially as a new adjunctive treatment of MDD in patients with an inadequate response to current FDA-approved antidepressants. AV-101 may also have the potential to treat neuropathic pain, epilepsy, Parkinson's disease levodopa-induced dyskinesia and other CNS diseases and disorders where NMDA receptor modulation and AMPA pathway activation may achieve therapeutic benefits.