Naurex commences dosing in its GLYX-13 Phase I clinical trial for treatment-resistant depression

Dec 16 2009

Naurex Inc., a new clinical stage company developing innovative treatments for depression and other CNS disorders based on its novel GFPA NMDA receptor modulators, today announced that it has initiated a Phase I clinical trial of its lead compound GLYX-13 and has successfully dosed the first subjects in the study. GLYX-13, a glycine site functional partial agonist (GFPA) selective modulator of the NMDA receptor, is initially being developed as a therapy for treatment-resistant depression in severely depressed patients admitted to the hospital. Separately, Naurex announced that data presented at a recent medical meeting reported that GLYX-13 demonstrated robust antidepressant-like and anxiolytic-like activity in animal models with no signs of the CNS-related side effects observed with other drugs targeting the NMDA receptor. The studies also showed that the antidepressant effects of GLYX-13 were evident within 20 minutes and demonstrated a lasting antidepressant effect of greater than four days after administration of a single dose. In these studies, GLYX-13 affected both the positive and negative symptoms of depression.

"Based on its demonstrated safety and antidepressant-like activity in well-validated animal models, we are pleased to have begun assessing GLYX-13 in human trials," said Ronald Burch, MD, PhD, chief medical officer at Naurex. "We are optimistic that this Phase I safety trial will pave the way for rapidly proceeding to more advanced trials in patients admitted to the hospital with severe treatment-resistant depression, a condition with an urgent need for additional treatment options."

The GLYX-13 Phase I trial is a randomized, double-blind, placebo-controlled single ascending dose level study of the safety, tolerability and pharmacokinetics of GLYX-13. The trial is currently recruiting and plans to enroll 20 healthy volunteers. The primary outcome measure is observed and laboratory-confirmed safety. Drug pharmacokinetics will also be measured.

The efficacy of NMDA receptor glycine site functional partial agonists has been demonstrated in animal models and early human studies in a number of CNS disorders, including major depressive disorder, neuropathic pain, schizophrenia, anxiety, Alzheimer's disease and other cognition disorders. In these studies, GFPA modulators did not exhibit the psychosis-like side effects associated with NMDA receptor blockers that interact with other binding sites on the receptor complex. GLYX-13 has demonstrated a wide therapeutic ratio (500:1) between efficacy and side effects, which is the largest therapeutic ratio of any reported molecule that interacts at the NMDA receptor.