Neurelis Finalizes Series A Financing to Advance Lead Program to NDA Filing
Neurelis, Inc., a specialty pharmaceutical company focused on the treatment of central nervous system disorders, today announced that it has finalized a Series A financing round. The investment, led by LYZZ Capital, is intended to advance the company's lead program, NRL-1 (intranasal diazepam), through the remaining clinical work in preparation for FDA submission of a New Drug Application (NDA) in the US. NRL-1 is being developed for pediatric, adolescent, and adult epilepsy patients who experience Acute Repetitive or Cluster Seizures. "This past year has been both productive and exciting for Neurelis, with the progress on the NRL-1 program and receiving Orphan Drug Designation for the product," stated Craig C. Chambliss, President and Chief Executive Officer of Neurelis. "This financing places us significantly closer to the goal of providing pediatric, adolescent, and adult epilepsy patients and caregivers with an effective, well-tolerated, and user-friendly product for the treatment of Acute Repetitive or Cluster Seizures. There is an incredible need for a convenient product to treat these seizures where they occur - at home, work, school, or wherever the need may arise."
NRL-1 (intranasal diazepam) is a proprietary formulation of diazepam, delivered via a nasal formulation in a spray, being developed for the management of pediatric and adult patients who require intermittent use of diazepam to control bouts of acute repetitive seizure activity, also known as cluster seizures. NRL-1 has been granted Orphan Drug Designation by the FDA. In clinical trials, NRL-1 has demonstrated high bioavailability, low variability from dose to dose, and was well-tolerated. There are over 2.7 million people with epilepsy in the United States with approximately 200,000 new patients diagnosed each year. It is estimated that between 30% and 40% of these patients are uncontrolled on oral therapy and are at-risk for acute breakthrough seizures. Studies have shown that prolonged or repetitive seizures can cause neurological damage and dramatically increase the risk of changes in neuropsychological function or even death.
Neurelis, Inc. is a privately-held San Diego-based specialty pharmaceutical company organized to license, develop, and commercialize product candidates for epilepsy and the broader central nervous system (CNS) market. Neurelis leverages expertise in the development and commercialization of CNS compounds and strong relationships with leading researchers and clinicians in these markets to advance unique product candidates to address significant unmet medical needs.