Naurex Inc., a clinical stage company developing innovative treatments to address unmet needs in psychiatry and neurology, today reported positive results from a Phase IIa clinical trial of its lead antidepressant compound, GLYX-13. GLYX-13 is a novel partial agonist of the NMDA receptor. The Phase Ila results are being presented this week at the 51st Annual Meeting of the American College of Neuropsychopharmacology (ACNP).
The Phase IIa results show that a single administration of GLYX-13 produced statistically significant reductions in depression scores in subjects who had failed treatment with one or more antidepressant agents. The reductions were evident within 24 hours and persisted for an average of seven days. Importantly, the effect size, a measure of the magnitude of the drug’s antidepressant efficacy, observed at 24 hours and at seven days after a single administration of GLYX-13, was nearly double the effect size seen with most other antidepressant drugs after 4-6 weeks of repeated dosing.
In the Phase IIa trial, GLYX-13 was well tolerated. Reported side effects were mild to moderate and were consistent with those observed in subjects receiving placebo. Consistent with previous studies, GLYX-13 did not produce any of the schizophrenia-like psychotomimetic effects associated with other drugs that modulate the NMDA receptor.
“These data are an important step in validating Naurex’s mission of developing breakthrough therapies for depression and other CNS disorders,” said Derek Small, CEO of Naurex. “Our founder discovered a new class of drugs that appeared to have the remarkable antidepressant efficacy of ketamine-like compounds, but without their limiting side effects. These Phase II results suggest that this discovery may translate into measurable health improvements for individuals with depression, which bodes well for the future success of GLYX-13 and the other promising compounds we have generated from this platform.”
Other NMDA receptor-modulating agents, such as ketamine, have been shown in several human clinical trials to act very rapidly to alleviate the symptoms of depression and bipolar disorder, but their clinical utility has been hampered by their potential for abuse and behavioral impairment, including schizophrenia-like effects at therapeutic doses.
“We are encouraged by these promising data,” noted Ronald M. Burch, MD, PhD, Chief Medical Officer of Naurex. “We have recently begun dosing patients in a GLYX-13 Phase Ilb repeated dose trial, and we are on track to advance our second-generation oral compound, NRX-1074, into clinical trials next year. Preclinical studies show that our novel NMDA modulators may be applicable to a number of CNS disorders, and we look forward to assessing their potential to address major unmet needs in psychiatry and neurology.”
The Phase Ila trial was a randomized, double blind, placebo-controlled study of the efficacy and safety of a single dose of intravenous GLYX-13 in subjects who had failed at least one other antidepressant during the current depressive episode. It was conducted at 12 clinical centers in the U.S. Outcome measures included ratings of signs, symptoms and changes in depression scores on standard rating scales for mood and psychiatric disorders. Independent raters from MedAvante, who were blinded to the protocol, administered certain psychiatric assessments for the trial to ensure the quality and objectivity of the screening and rating data. Safety was also assessed.