Naurex Presents Data on Rapid-Acting Antidepressant GLYX-13 that Support Long-term Synaptic Plasticity as Its Mechanism of Action

-Preclinical data on novel antidepressant in phase 2b clinical trials presented at American College of Neuropsychopharmacology 52nd Annual Meeting-

Dec 12, 2013, 08:00 ET from Naurex Inc.

EVANSTON, Ill., Dec. 12, 2013 /PRNewswire/ -- Naurex Inc. today announced the presentation of preclinical data at the 52nd Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in Hollywood, Fla, showing that its rapid-acting novel antidepressant GLYX-13 enhances synaptic plasticity, its hypothesized mechanism of action.  In these studies, GLYX-13 also enhanced enrichment of specific genes associated with synaptic plasticity and long-term depression.  GLYX-13 is currently in a Phase 2b repeat dose clinical trial in patients with depression who experience an inadequate response to their current antidepressants. In an earlier Phase 2 trial, a single dose of GLYX-13 produced statistically significant and long-lasting reductions in depression scores within 24 hours in patients with major depressive disorder who had failed treatment with one or more antidepressant agents. 

"These preclinical studies were designed to help us better understand the mechanism of action underlying the rapid and long-lasting antidepressant effect that was observed in our single-dose Phase 2 trial of GLYX-13 and that was also confirmed in these studies," said Joseph Moskal, Ph.D., chief scientific officer of Naurex and the senior author of the paper. "The studies showed that synaptic plasticity and expression of genes associated with both synaptic plasticity and long-term depression increased with single doses and were further enhanced with repeated doses of GLYX-13. These results support synaptic plasticity as an important mechanism of action of GLYX-13."

Derek Small, president and chief executive officer of Naurex added, "These data are important validation and further elucidate the mechanism by which GLYX-13 produces the rapid and prolonged antidepressant effect we've seen in patients. Modulating the activity of the NMDA receptor (NMDAR) via functional partial agonism is the key to understanding how GLYX-13 produces its positive clinical effects while avoiding many of the side effects associated with other drugs that target the NMDAR. Data from the Phase 2b trial are expected early in 2014."

Abstract W190, Wednesday, Dec. 11, 5:30 p.m. - 7:30 p.m. EST: GLYX-13, a NMDA Receptor Glycine-Site Functional Partial Agonist, Produces Long Lasting Antidepressant-like Effects through Modulation of Long-term Synaptic Plasticity
J. S. Burgdorf, X-L. Zhang, A.L. Gross, R. A. Kroes, P. K. Stanton, J.D. Leander, R.M. Burch and J. R. Moskal

Moskal et al., GLYX-13, an NMDA receptor glycine site functional partial agonist enhances cognition and produces antidepressant effects without the psychotomimetic side effects of NMDA receptor antagonists. J. Expert Opin. Investig. Drugs. 2013 Nov. 20.

Burgdorf et al., GLYX-13, a NMDA receptor glycine-site functional partial agonist, induces antidepressant-like effects without ketamine-like side effects. Nature Neuropsychopharmacology. 2013 Apr., 38(5):729-42. doi: 10.1038/npp.2012.246.

About Naurex

Naurex Inc. is a clinical-stage biopharmaceutical company developing rapid-acting drugs to address difficult-to-treat depression as well as orphan and other challenging CNS diseases treated in specialty settings. The company's two fast-acting antidepressants, currently in the clinic, were developed utilizing Naurex's proprietary platform for discovering compounds that modulate the NMDA receptor (NMDAR) to affect synaptic plasticity. Binding to specific sites on the NMDAR and acting as partial agonists, all of Naurex's compounds are designed with the goal of providing the clinically-validated superior efficacy associated with targeting the NMDAR without the limiting side effects.

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