Virpax to Develop CBD Nasal Spray for Epilepsy
Under the agreement, Virpax can develop, manufacture, and sell VRP324, an investigational formulation of cannabidiol (CBD) administered using a nasal spray to enhance delivery directly to the brain. Cannabidiol is derived from the cannabis plant but does not have psychoactive effects.
Nanomerics already has begun preclinical studies of VRP324 in animals. If successful, Virpax plans to seek permission, via a pre-investigational new drug (IND) application, from the U.S. Food and Drug Administration to test the therapy in humans, they said.
“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,” Anthony Mack, chairman and CEO of Virpax, said in a press release.
The therapy takes advantage of Nanomeric’s molecular envelope platform technology (MET), designed to maximize the amount of medicine available at the site of disease. MET allows efficient loading of medicines into tiny nanoparticles, as well as rapid release, to deliver therapies via the nose-to-brain route.
The MET nanoparticles have been well-tolerated in animal studies using the nasal spray platform, the company said.
VRP324 is manufactured using high-pressure purification and spray drying and encapsulated in a preassembled device and cartridge to propel CBD powder into the nose to the olfactory nerve, which senses smell.
The potential therapy will be formulated to treat epileptic seizures associated with Dravet syndrome as well as Lennox-Gastaut syndrome in patients 1 year and older. VRP324 also may help those with epilepsy related to tuberous sclerosis complex (TSC), a rare genetic disease that causes non-cancerous (benign) tumors to grow in the brain and other organs.
An oral formulation of CBD, Epidiolex by GW Pharmaceuticals, is approved in the U.S. to treat seizures in people with Dravet syndrome and Lennox-Gastaut syndrome, ages 1 and older. Because the oral medication passes through the liver, it can interact with other therapies, altering their metabolism and affecting the dose.
Using a nasal spray, this new CBD administration may bypass the liver and avoid these unwanted effects. Virpax currently markets Envelta, a pain medication that is delivered through the nose by the same platform.
“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,” Mack said.
“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,” he said.