EVANSTON, Ill., Jan. 27, 2015 /PRNewswire/ -- Naurex Inc., a biopharmaceutical company leveraging its unique platform to develop novel drugs for diseases of the central nervous system (CNS), today announced that a single intravenous dose of NRX-1074 resulted in a statistically significant improvement in depression scores within 24 hours in a Phase 2 single-dose study in subjects with major depressive disorder (MDD). The orally active NMDA receptor modulator, NRX-1074, is a follow up to Naurex's lead program, rapastinel (GLYX-13), which recently demonstrated robust and durable antidepressant effects in a Phase 2b study as an intravenous adjunctive therapy in subjects with partial but inadequate response to existing antidepressants.
"The reductions in depression symptoms we saw from a single dose of NRX-1074 in this study were among the most substantial I have observed in antidepressant clinical development," said Susan McElroy, M.D., a study investigator and professor of psychiatry and behavioral neuroscience at the University of Cincinnati College of Medicine. "This level of effect will likely have a very positive impact on patients' lives. There is a significant need for treatment options that are able to bring rapid and meaningful benefits to patients struggling with depression. We look forward to continuing to study the benefit of this therapy, including in the upcoming repeat-dose trial."
At the highest and most effective dose level, the average reduction in HDRS-17 scores at 24 hours was 14 points, with a mean difference from placebo of 7 points (p=0.0029). The effect size, a statistical index measure of the magnitude of the drug's antidepressant efficacy, observed at 24 hours after dosing was 0.88 – more than double the effect size seen with most other antidepressant drugs after four to six weeks of repeated dosing. Clinical response to NRX-1074 was also significantly different from placebo, with 72 percent of subjects receiving the highest dose of the compound demonstrating a clinically meaningful response at 24 hours (defined as at least a 50 percent reduction in HDRS-17 score from baseline) compared to 39 percent of subjects given placebo (p=0.038). A clear dose response was observed across the three dose levels tested. The study utilized an intravenous formulation to inform dose selection for an upcoming repeat-dose Phase 2 study with the oral form.
"These positive data offer clear clinical validation of the differentiated efficacy and safety of the first orally available molecule from our NMDA receptor modulation platform," said Norbert Riedel, Ph.D., president and chief executive officer of Naurex. "We are in an advantageous position to have two complementary late-stage assets with compelling clinical data in depression that can serve different needs in clinical practice. Rapastinel is being developed as an adjunctive treatment for difficult-to-treat major depressive disorder, while orally available NRX-1074 has the potential to be an early-line monotherapy. The two compounds could help a wide range of patients suffering from depression."
In the study, which enrolled approximately 140 subjects, NRX-1074 was well-tolerated with no drug-related serious adverse events reported and no subjects dropping out of the study due to adverse events. This safety profile was also observed in Phase 1 studies with both intravenous and oral NRX-1074 in healthy volunteers.
Findings from the Phase 2 single-dose study, along with oral and intravenous pharmacokinetic findings from Phase 1, will be used to select oral doses for a repeat-dose Phase 2 study. This upcoming randomized, double-blind, placebo-controlled multi-dose study will evaluate the efficacy and safety of repeated oral dosing of NRX-1074 administered as a monotherapy to subjects with MDD.
The randomized, double-blind, placebo-controlled Phase 2 study evaluated the efficacy and safety of a single intravenous dose of NRX-1074 in subjects with MDD. The study was conducted at 12 clinical centers in the United States. Subjects received one of three dose levels of NRX-1074 or placebo. The primary clinical efficacy measure was the HDRS-17, a standard scale for measuring depression severity, which was administered by off-site independent raters who were blinded to the protocol to ensure the quality and objectivity of the rating data. Safety was also assessed.
Naurex's proprietary drug discovery platform is based on the pioneering work of company founder Joseph Moskal, Ph.D. and his colleagues at the Falk Center for Molecular Therapeutics at Northwestern University. Naurex retains exclusive worldwide development and commercialization rights for the discovery platform and all resulting molecules, including rapastinel (GLYX-13) and NRX-1074.
About Naurex Inc.
Naurex is a clinical-stage biopharmaceutical company developing transformative therapies for challenging disorders of the central nervous system. The company has built a platform for discovering drugs that enhance synaptic plasticity, or strengthen the network for neural cell communication. Molecules discovered by Naurex achieve this through a novel mechanism that modulates the NMDA receptor – rather than shutting it down – resulting in drugs that are both highly effective and well tolerated. Naurex's lead molecule, rapastinel (GLYX-13), is Phase 3-ready, having demonstrated rapid, robust and sustained efficacy in multiple Phase 2 clinical studies in depression, an area of high unmet need that has seen little innovation in decades. NRX-1074, a next-generation, orally bioavailable drug candidate, has also shown rapid and robust antidepressant efficacy in Phase 2. Naurex's platform has yielded a rich pipeline of subtype-selective NMDA receptor modulators with the potential to treat a broad set of psychiatric and neurologic disorders.
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SOURCE Naurex Inc.