NeurOp Receives FDA Orphan Drug Designation for NP10679 for Treatment of Subarachnoid Hemorrhage

Atlanta, GA – December 8, 2021 – NeurOp, Inc., a clinical-stage biotechnology company focused on neurological and psychiatric disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s investigational candidate NP10679 for the treatment of subarachnoid hemorrhage (SAH).

SAH is a life-threatening type of stroke caused by bleeding into the space surrounding the brain. In patients who experience SAH caused by a ruptured aneurysm, vasospasm producing ischemic damage occurs in over one-third of patients during the week following the event and often results in permanent disability or death.

The mechanism by which ischemia damages the brain involves overactivation of NMDA receptors. Ischemia also induces acidity of brain tissue. Together, these insights led NeurOp to develop NMDA receptor blockers with increased potency in acidic tissue. NeurOp’s lead compound NP10679 is a highly selective antagonist for NMDA receptors and has greater potency in acidic conditions. These properties will enable it to provide neuroprotection against ischemic injury caused by vasospasm in SAH with fewer negative side effects than currently available NMDA inhibitors and other treatments.

“NP10679 demonstrated safety, tolerability and positive pharmacokinetics in our Phase 1 studies that make it an attractive candidate for prophylactic treatment following SAH,” said James McNamara, M.D., Executive Chairman of NeurOp. “Based on its encouraging profile, we look forward to commencing a Phase 2 clinical trial of NP10679 for SAH in 2023.”

The FDA Office of Orphan Products Development grants orphan drug designation to investigational drugs and biologics intended for the treatment, diagnosis or prevention of rare diseases, which are defined as those that affect fewer than 200,000 people in the U.S. The program provides certain benefits that include tax credits and application fee waivers designed to offset some development costs, as well as seven-year marketing exclusivity to sponsors of approved orphan products.

About NP10679
NeurOp is developing NP10679 as a subunit-specific NMDA receptor inhibitor for CNS disorders. NMDA receptors are activated by the neurotransmitter glutamate, the predominant excitatory transmitter in the brain. Several neurological disorders, including pain, treatment-resistant depression and brain damage resulting from acute brain injury, such as stroke or SAH, are associated with overactivity of these receptors. NP10679 is selective for a specific NMDA subtype, GluN2B, and has increased potency in acidic conditions. Its enhanced selectivity and disease context-dependent target engagement may provide neuroprotection with fewer negative side effects than currently available NMDA inhibitors.

About NeurOp, Inc.
NeurOp, Inc. is a privately held, clinical-stage biopharmaceutical company based in Atlanta, Georgia that is developing small-molecule therapies for central nervous system disorders, including severe pain, treatment-resistant depression, subarachnoid hemorrhage (SAH) and stroke. Its proprietary compounds selectively inhibit the GluN2B subunit of neuronal NMDA receptors and are designed for potential therapeutic benefit with an improved safety and tolerability profile relative to other NMDA receptor antagonists. For more information, please visit www.neuropinc.com or follow us on LinkedIn.

NIH Awards NeurOp $3.5 Million to Support Phase 1 Clinical Trial of NMDA Inhibitor NP10679

NP10679 is in development to prevent brain ischemia during stroke or subarachnoid hemorrhage

NeurOp, Inc. today announced that it has received a $3.5 million award from the National Institute of Neurological Disorders and Stroke (NINDS), a division of the NIH, to begin clinical testing of the Company’s drug candidate NP10679, a GluN2B subunit-specific NMDA (N-methyl-D-aspartate) inhibitor. NeurOp is investigating NP10679 for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage (SAH).

“We designed NP10679 with great care to incorporate the attributes we believe differentiate this molecule from other NMDA inhibitors in development,” said Barney Koszalka, PhD, NeurOp CEO. “For example, the binding of the molecule is enhanced in an acidic environment, a property other NMDA inhibitors lack. This property of pH dependence improves the chance of achieving efficacy at dose levels devoid of side effects. We would like to partner with a pharmaceutical company in future trials to fully explore this advantage in an array of disorders such as stroke, treatment-resistant depression and neuropathic pain.”

NP10679 is bioavailable by either the oral or IV route, and it will initially be evaluated in a Phase 1 study in healthy human volunteers by the IV route. The study is expected to start in early 2018. Pre-clinical studies have shown efficacy in treating complications associated with SAH. An IND for NP10679 was opened in 2016.

NeurOp’s Chief Scientific Officer, Robert Zaczek, PhD, added, “The safety profile of NP10679 allows for prophylactic use in patients at risk for an ischemic event, such as those suffering an SAH. This is important because extensive data has shown that early intervention is key for robust efficacy of neuroprotective therapy. Our prophylactic intervention strategy will place NP10679 at its site of action before an SAH-driven delayed cerebral ischemia event takes place. This eliminates the time-of-dosing caveat that might, in part, have led to previous failures of clinical tests involving glutamatergic agents in stroke and head trauma.”

Note: Research reported in this news release is supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health (NIH) under Award Number R44NS071657. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

About NeurOp
NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia and Parkinson’s disease. Its research targets specific subunits of neuronal NMDA receptors to identify and evaluate small molecule modulators for potential therapeutic benefit. Multi-year funding from the NIH supports the Company’s research and development programs for NP10679 for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage. For more information, please visit www.neuropinc.com.

NeurOp contact:
Barney Koszalka, PhD, CEO