Naurex Inc., a clinical stage company developing innovative treatments for depression and other CNS disorders based on its novel glycine site functional partial agonist (GFPA) NMDA receptor modulators, today reported positive top-line results from its Phase I clinical trial of lead compound GLYX-13. GLYX-13 is a GFPA selective modulator of the NMDA receptor. It is initially being developed as a therapy for treatment-resistant depression in severely depressed patients. In the Phase I trial, adverse events were similar for subjects receiving GLYX-13 and placebo and were all rated as mild. There were no signs of the schizophrenia-like side effects associated with other NMDA receptor modulator drugs.
"These encouraging data in humans are consistent with the excellent safety profile demonstrated in preclinical studies of GLYX-13," said Ronald Burch, M.D., Ph.D., chief medical officer at Naurex. "In view of the history of schizophrenia-like side effects caused by NMDA receptor modulators such as ketamine and CP-101,606, we are very pleased that there were no signs of these effects in this first trial of GLYX-13 in humans, even at higher doses than we expect would be required to provide antidepressant effects. The pharmacokinetics of GLYX-13 also was encouraging, with similar or greater drug exposure seen in humans than in animals at the same doses. These positive results will allow us to proceed to Phase II clinical trials in patients with severe treatment-resistant depression, a condition with an urgent need for better treatment options."
The GLYX-13 Phase I trial was a randomized, double-blind, placebo-controlled single ascending dose level study of the safety, tolerability and pharmacokinetics of four dose levels of GLYX-13 in healthy volunteers. The primary outcome measures included observational and laboratory-confirmed safety parameters. Schizophrenia-like side effects were specifically evaluated.