20 Sept. 2021. A company is developing a nasal spray for epilepsy symptoms with a cannabis extract delivered in nanoscale polymer particles to the brain. Virpax Pharmaceuticals Inc. in Berwyn, Pennsylvania is extending its existing license agreement for the drug delivery technology made by Nanomerics Ltd. in London, U.K.
Virpax Pharma develops non-addictive pain treatments and neurological therapies delivered as directly as possible to the source of the conditions, instead of most current systemic therapies given as oral or injected drugs. One of its product lines delivers therapeutic peptides, short chains of amino acids, as a nasal spray where, according to the company, the inhaled peptides can cross the blood-brain barrier to ease pain from cancer and other sources, and treat post-traumatic stress disorder or PTSD. The nasal sprays are packaged in single-use cartridges, and sent through the nose with an inert gas, which can be administered by a clinician or caregiver if needed.
Delivery of these therapies uses a process licensed from Nanomerics called molecular envelope technology. With this technology, Nanomerics encapsulates therapeutic molecules in nanoscale biocompatible polymer particles, 50 to 300 nanometers in size. Nanomerics says the polymers self-assemble around insoluble or peptide molecules, providing stability in transit and releasing their contents rapidly on delivery. As a result, says Nanomerics, higher doses of drugs can be delivered more safely to their targets, including to brain cells.
Under the agreement, Virpax Pharma is receiving an exclusive worldwide license from Nanomerics to apply molecular envelope technology to a nasal spray treating epilepsy-type seizures with a cannabidiol or CBD compound. The deal also calls for Nanomerics to conduct preclinical animal tests of Virpax’s CBD candidate code-named VRP324. Financial terms of the agreement were not disclosed.
Through olfactory nerve to the brain
CBDs are derived from the Cannabis sativa plant, but do not produce an emotional high associated with marijuana, also a derivative of cannabis. National Library of Medicine in the U.S. says some 80 chemicals, known as cannabinoids, are associated with these plants. One of those chemicals, CBD, a non-intoxicating derivative, makes up about 40 percent of cannabis extracts and has been studied extensively for a range of disorders. Epilepsy and related disorders are shown to respond to CBD, and in 2018 the Food and Drug Administration approved a CBD-based therapy for Lennox-Gastaut syndrome and Dravet syndrome, two rare and severe forms of epilepsy.
Virpax Pharma is developing VRP324 for patients one year or older, delivered as a powder into the nose and through the olfactory nerve to the brain for seizures associated with tuberous sclerosis complex, a rare genetic condition where benign tumors grow in the brain. Tuberous sclerosis complex can also cause impaired intellectual development, autism, and behavioral problems, but may take years for symptoms to appear. Virpax says VRP324 is being developed as well for treating Lennox-Gastaut syndrome and Dravet syndrome.
Anthony Mack, chairman and CEO of Virpax Pharma, says in a company statement that the company’s tests show delivery through the nose bypasses the liver, and “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.” Mack adds, “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.”
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