SAN DIEGO, Jan. 5, 2017 /PRNewswire/ -- 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.
About NRL-1
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.
About Neurelis
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. For
more information, go to www.neurelis.com.