Naurex Inc., a privately held biopharmaceutical company leveraging its unique platform to develop novel drugs for diseases of the central nervous system (CNS), today announced that its two lead antidepressant programs achieved major milestones. Top-line results from a Phase 2b clinical study of the company's lead compound, GLYX-13, showed that the drug was well-tolerated and that the rapid, robust, and sustained antidepressant effects observed in an earlier single-dose study were achieved and maintained with repeat dosing in subjects with difficult-to-treat depression.
The company also reported that it initiated a Phase 2a study of its second-generation, orally active agent, NRX-1074, based on positive results from a recently completed Phase 1 study. NRX-1074 is in development for major depressive disorder (MDD).
Additionally, Naurex announced that existing shareholders, which include multiple venture funds and pharmaceutical companies, have invested an additional $25 million in the company.
Norbert Riedel, PhD, president and chief executive officer of Naurex, commented, "These advances highlight the breakthrough potential of our proprietary platform for addressing CNS disorders through an entirely new mechanism—modulating the NMDA receptor to affect pathways involved in neuroplasticity with excellent efficacy and tolerability. The promising top-line data from our repeat-dose study of GLYX-13 continue the remarkably consistent pattern of activity and safety observed across all preclinical and clinical studies to date. These results suggest that GLYX-13 has the potential to address the most important unmet medical needs confronting millions of patients with depression worldwide."
The Phase 2b GLYX-13 study was conducted across 25 U.S. sites that enrolled more than 400 subjects with MDD who had an inadequate response to their current antidepressants. The top-line results confirmed that repeat dosing of GLYX-13 resulted in the maintenance of marked and clinically meaningful antidepressant effects. No drug-related serious adverse events were reported, no subjects dropped out of the study due to drug-related adverse events, and there were no signs of the psychotomimetic side effects associated with NMDA receptor antagonists, such as ketamine.
John Krystal, MD, the Robert L. McNeil Jr. professor of psychiatry, professor of neurobiology, and chair of the department of psychiatry at the Yale School of Medicine and chief of psychiatry at Yale-New Haven Hospital, commented, "Current antidepressants are relatively slow to act, may be associated with side effects, and are not sufficiently effective for many patients. These GLYX-13 data are very exciting. They underscore the novelty and potential effectiveness of targeting the glutamate system for the treatment of depression. We look forward to learning more as additional data from the study become available."
Sheldon Preskorn, MD, a study investigator and professor of psychiatry at the University of Kansas School of Medicine-Wichita, said, "We are very pleased that the encouraging effects observed in the single-dose GLYX-13 study have been replicated in this larger, repeat-dose study. GLYX-13 and NRX-1074 are at the forefront of a new class of subtype-selective NMDA receptor modulators that could represent a major breakthrough in CNS medicine and the effort to address the suffering of people battling difficult-to-treat depression."
The objectives of the Phase 2a study now underway for NRX-1074 are to evaluate the safety and efficacy of a single dose of the compound administered to subjects with MDD. NRX-1074 is considerably more potent than GLYX-13 and, in preclinical studies, it has shown activity similar to GLYX-13, including signs of rapid onset and long-acting duration of antidepressant-like effect. The Phase 2a study of NRX-1074 follows successful completion of a randomized, placebo-controlled Phase 1 study in which NRX-1074 was well-tolerated by normal volunteers.
Dr. Riedel added, "We are also pleased by the excellent tolerability observed to date with our second-generation NMDA receptor modulator, NRX-1074. We are optimistic about the prospects for this compound—which is similar to GLYX-13 but more potent and orally active—as it advances through Phase 2 clinical development for major depressive disorder."
Naurex's proprietary drug discovery platform is based on the pioneering work of company founder Joseph Moskal, PhD and his colleagues at the Falk Center for Molecular Therapeutics at Northwestern University. Naurex retains worldwide development and commercialization rights for the discovery platform and all resultant molecules.