NeurOp, Inc., a clinical-stage biotechnology company, today announced the initiation of a Phase 1 clinical trial of NP10679, a highly potent and selective GluN2B subunit-specific NMDA (N-methyl-D-aspartate) receptor inhibitor. NeurOp is investigating NP10679 for several neurological disorders that are associated with over-activity of these receptors.
The randomized, placebo-controlled, single ascending dose study will assess the safety, pharmacokinetics and pharmacodynamics of NP10679 in healthy volunteers. The study is being conducted in collaboration with Pharmaron (Baltimore) and is currently enrolling subjects in the United States. Data collected from the study will inform dose and schedule for further development of NP10679 for potential use in severe pain and the prevention of ischemic damage following subarachnoid hemorrhage (SAH).
Certain areas of the brain become acidified by metabolic insufficiency or increased neuronal activity. This condition or “context” exists in severe pain and SAH and may also exist in brain areas that are undergoing seizures or involved in nicotine or opioid addiction.
“NP10679 is a first-in-class therapy as a context-dependent NMDA receptor inhibitor,” said NeurOp’s Chief Scientific Officer, Robert Zaczek, PhD. “Preclinical data demonstrate that NP10679 is different from other NMDA therapies, because of its selectivity, safety profile and potency at low pH, a condition found in a number of central nervous system disorders.”
“We have achieved a significant milestone for NeurOp now that NP10679 has advanced to the clinic,” said James McNamara, MD, Executive Chairman at NeurOp. “We look forward to moving this compound through clinical development and are particularly encouraged by its potential as a treatment for severe pain. With the opioid epidemic facing the nation, the need for effective and safe medications for severe pain is greater than ever.”
NP10679 is bioavailable either orally or by IV, and it is currently being evaluated in this study by the IV route. An IND for NP10679 was opened in 2016.
NeurOp, Inc. is a clinical-stage biopharmaceutical company based in Atlanta that is developing small-molecule therapies for central nervous system disorders, including severe pain, subarachnoid hemorrhage (SAH) and catastrophic juvenile epilepsies. Its proprietary compounds selectively inhibit the GluN2B subunit of neuronal NMDA receptors for potential therapeutic benefit with fewer side effects than currently available NMDA receptor antagonists. For more information, please visit www.neuropinc.com.
Robert Zaczek, PhD