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

NeurOp, Inc., a clinical-stage biotechnology company focused on neurological and psychiatric disorders, 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.