Virpax Successfully Completes Initial Preclinical Studies for VRP324
Virpax Pharmaceuticals (NASDAQ: VRPX) has reported promising preclinical pharmacokinetics results for VRP324, a nasal CBD candidate designed for seizure management in children and adults. The study indicates effective nose-to-brain delivery, achieving higher CBD concentrations in the brain compared to plasma. This method may lead to reduced side effects and drug interactions. The company is preparing a pre-IND application for FDA review, targeting seizures related to disorders like Lennox-Gastaut syndrome and Dravet syndrome.
- Successful preclinical pharmacokinetics results for VRP324.
- Higher CBD concentrations in the brain via nasal delivery compared to oral forms.
- Potential for reduced side effects and interactions due to avoidance of liver first-pass metabolism.
- Plans to proceed with FDA pre-IND application for VRP324.
- None.
-Nasal CBD Candidate to Manage Seizures Associated with Epilepsy in Children and Adults-
Virpax believes that VRP324 may achieve higher efficiency via the nasal route compared to the oral CBD product on the market since peripheral exposure via plasma may be reduced by the nose-to-brain delivery. Evidence suggests that compared to the commercialized oral-dosed CBD, the nose-to-brain CBD formulation may have negligible liver first-pass metabolism, thereby avoiding drug to drug interactions and potentially producing fewer side effects. By avoiding the first pass effect, intranasal VRP324 may also eliminate enzymatic degradation.
“The results from this preclinical PK study met our expectations. We are encouraged that our molecular envelope technology (MET) may offer a more effective and efficient delivery method than the approved oral formulation, especially for children who suffer from seizure disorders. As previously stated, we plan to immediately proceed with preparing a pre-IND application briefing document for the
VRP324 uses a preassembled device and cartridge to propel the MET-CBD powder formulation into the nose via the olfactory nerve/bulb. This product candidate has been 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, and cognitive and behavioral changes. These syndromes have historically been resistant to treatment.
“We are pleased to have generated successful preclinical PK data in support of the exclusive license for VRP324, previously granted to Virpax by
About VRP324
VRP324 is a drug product candidate based on nanotechnology enabling the delivery of CBD into the brain via intranasal delivery for the management of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older, as well as patients one year of age and older who experience seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome. VRP324 is manufactured using high pressure homogenization and spray drying. In animal studies, the MET nanoparticles are well-tolerated via the nasal route at the dose administered.
About Nanomerics
About
Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval of its three patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage osteoarthritis pain. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular-Envelope Technology (MET) enkephalin formulation being developed for the management post cancer pain and non-cancer pain, as well as post-traumatic stress disorder (PTSD) under the name PES200. MET technology is also used in AnQlar™, a candidate to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax recently acquired global rights to VRP324, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of rare pediatric epilepsy. For more information, please visit www.virpaxpharma.com.
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