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Naurex’s lead compound GLYX-13 is a novel NMDAR Glycine-site Functional Partial Agonist (GFPA) in development for the treatment of depression. GLYX-13 has shown promising results in a Phase I clinical trial and in preclinical studies. A Phase II trial evaluating the use of GLYX-13 in patients who are not achieving adequate responses to their current antidepressant regimens is underway.
GLYX-13 preclinical data presented at a major medical meeting showed that it demonstrated:
- Robust antidepressant-like activity.
- An immediate onset of effect—the antidepressant effects of GLYX-13 were evident within 20 minutes of administering a single dose.
- A long-acting duration of effect—demonstrating an antidepressant-like effect lasting at least two weeks after a single dose.
- No signs of CNS-related side effects, achieving a therapeutic index of 500 or more—an unprecedented result for drugs targeting the NMDA receptor.
GLYX-13 Clinical Trials
Naurex is currently conducting a Phase II proof-of-concept trial testing GLYX-13 in patients with depression who are experiencing inadequate response to their current antidepressant agents. Initial results from this trial are expected during 2012.
The GLYX-13 Phase II trial is a randomized, double- blind, placebo-controlled study of the efficacy and safety of GLYX-13 in treatment-resistant depression. The trial is intended to enroll 80 subjects with major depressive disorder who have demonstrated inadequate or partial response to other antidepressants. Outcome measures include ratings of signs, symptoms and changes in depression scores on standard rating scales for mood and psychiatric disorders. Safety is also being assessed. To learn more about the Phase II clinical trial, please visit the trial’s ClinicalTrials.gov listing.
Naurex has reported results from a Phase I trial of GLYX-13. The Phase I data showed that adverse events for the groups receiving GLYX-13 and placebo were all rated as mild, and there were no signs of the schizophrenia-like side effects associated with other drugs that modulate the NMDA receptor.
The 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, including schizophrenia-like side effects. None were observed, even following administration of single doses of GLYX-13 that were significantly higher than the expected therapeutic dose based on data from animal studies. The pharmacokinetics of GLYX-13 demonstrated drug exposure in humans that correlated to exposure in animals at the same doses.