Neurelis Completes Series B Financing
Neurelis, Inc. today announced that it has finalized a Series B financing round led by HBM Healthcare Investments. In addition, LYZZ Capital, which led the Series A funding for Neurelis, has participated in the Series B round. The company will utilize the funds to complete clinical trials for NRL-1 (intranasal diazepam), prepare the planned New Drug Application (NDA) for submission to the U.S. Food and Drug Administration (FDA), and begin preparations for the commercial launch of the product. NRL-1 is being developed for pediatric, adolescent, and adult epilepsy patients who experience acute repetitive or cluster seizures. The program is in the final phase of clinical development and the NDA application is planned for submission in 2018.
"We are very excited to have completed the company's Series B financing round," said Craig C. Chambliss, President and Chief Executive Officer of Neurelis. "We are pleased to bring an outstanding investor in HBM Healthcare to the Neurelis team and greatly appreciate the continued confidence that LYZZ Capital has shown with their full participation in this financing. We can now complete the clinical development work for NRL-1, assemble our NDA submission, and prepare for the commercialization of this important Orphan Drug product for the epilepsy community."
On Wednesday, the company announced that that the FDA has designated NRL-1 as a Fast Track Development program. The Company had previously received Orphan Drug designation for the NRL-1 in November of 2015. There is a significant unmet clinical need that exists for epilepsy patients suffering from acute repetitive or cluster seizures. The only approved product currently available, Diastat®, requires rectal administration. This can be an issue – especially with adolescent and adult patients. NRL-1 was developed as a unique formulation which allows delivery of a therapeutic dose of diazepam via a well-tolerated nasal spray in order to provide rapid treatment of these seizures where they occur — at home, work, school or elsewhere.
NRL-1 (intranasal diazepam) is a proprietary patented 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 and Fast Track Designations by the FDA. In clinical trials, NRL-1 has demonstrated high bioavailability, low variability from dose to dose, and was well-tolerated.
Acute Repetitive/Cluster Seizures
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. Acute repetitive or cluster seizures may occur over a number of hours or days and can include any seizure type. 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 is leveraging its 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, such as NRL-1 for the treatment of acute repetitive or cluster seizures, to address significant unmet medical needs.