Naurex Inc., a clinical stage company developing innovative treatments for depression and other CNS disorders, today reported that it presented data at the NCDEU 50th Anniversary Meeting showing that its novel mechanism compound GLYX-13 appeared safe in a Phase I trial. GLYX-13 is a glycine site functional partial agonist (GFPA) selective modulator of the NMDA receptor that is being developed initially for use in depression as adjunctive therapy. The Phase I data showed that adverse events for the groups receiving GLYX-13 and placebo were all rated as mild. There were no signs of the schizophrenia-like side effects associated with other drugs that modulate the NMDA receptor.
"These promising initial data in humans are consistent with the excellent safety profile GLYX-13 demonstrated in preclinical studies," said Ronald Burch, M.D., Ph.D., chief medical officer at Naurex. "Our goal in developing GLYX-13 is to realize the superior efficacy and speed of onset observed with traditional NMDA receptor modulators, but without the schizophrenia-like side effects that have limited their use. We are encouraged that there was no sign of these effects in this study, especially since they have been observed in past studies of NMDA modulating agents in healthy volunteers. Based on these positive results, and following a recent meeting with the FDA, we are on track to initiate a Phase II proof-of-concept trial later this year in patients with depression who are experiencing inadequate response to their current antidepressant agent."
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 encompassed observational and laboratory safety parameters, including schizophrenia-like side effects. Adverse events for subjects receiving placebo and GLYX-13 were all rated as mild. No schizophrenia-like side effects were observed, even following administration of single doses of GLYX-13 that were 10-times higher than the expected therapeutic dose based on data from animal studies. The pharmacokinetics of GLYX-13 demonstrated similar or greater drug exposure in humans than in animals at the same doses.
NCDEU is a scientific meeting that focuses on the latest developments in psychopharmacologic clinical research and related methodology in the field of mental health. It is co-sponsored by the National Institute of Mental Health and the American Society of Clinical Psychopharmacology and brings together over 1200 academic and industry investigators, research pharmacists and clinicians. The NCDEU 50th Anniversary Meeting is being held June 14–June 17, 2010, at the Boca Raton Hotel in Boca Raton, Florida.