BERWYN, PA — Virpax® Pharmaceuticals, Inc. (NASDAQ: VRPX) has acquired the exclusive worldwide rights from Nanomerics Ltd. to use Nanomeric’s molecular envelope platform technology (MET) for the nasal delivery of a cannabidiol (CBD) for the management of epilepsy in adults and children.
Under the license agreement with Nanomerics, Virpax has the right to develop, manufacture, market and sell VRP324, the first investigational formulation delivered via the nasal route to enhance CBD transport to the brain. VRP324 uses a preassembled device and cartridge to propel the CBD powder formulation into the nose to the brain via the olfactory nerve/bulb. This product candidate will be formulated to potentially treat seizures associated with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome and Dravet syndrome in patients one year of age and older. Lennox-Gastaut syndrome and Dravet syndrome are rare central nervous system diseases considered serious epileptic encephalopathies that cause different types of epileptic seizures as well as cognitive and behavioral changes and are generally resistant to treatment. Nanomerics has initiated preclinical studies of VRP324. If animal studies are successfully completed, Virpax plans to immediately proceed with preparing a pre-Investigational New Drug Application briefing document for the U.S. Food and Drug Administration’s review.
“We believe VRP324 is the first step toward building our neurological disorder therapy pipeline, expanding the use of our novel delivery platform technologies to multiple categories of neurology,” said Anthony P. Mack, Chairman and CEO of Virpax. “Our Envelta™ IND enabling studies completed by the National Center for Advancing Translational Sciences as a part of our Cooperative Research and Development Agreement, have determined that the MET intranasal delivery formulation bypasses the liver. Consequently, we believe that since the CBD will not be metabolized in the liver, this may reduce the concern of drug-to-drug interaction and/or the need to adjust the dosage of other related medications,” concluded Mr. Mack.
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