Virpax -Model NobrXiol -Intranasal Pharmaceutical-Grade Cannabidiol (CBD)
Benefits: NobrXiol may be using significantly less pharmaceutical-grade CBD than current FDA approved oral CBD dosing. NobrXiol may achieve higher efficiency via the nasal route and reduce peripheral side effects like dose dumping due to high-fat meals. Since peripheral exposure via the plasma will be reduced by the nose to brain delivery, we believe there will be negligible liver first-pass metabolism. NobrXiol may not be metabolized in the liver avoiding drug to drug interactions caused by oral pharmaceutical-grade CBD. By avoiding the first pass effect Intranasal NobrXiol may eliminate enzymatic degradation or deactivation. Enzymatic deactivation occurs when an enzyme changes the structure of a neurotransmitter so that the receptor no longer recognizes the neurotransmitter.
Management of Rare Pediatric Epilepsy; Orphan Disease
Intranasal Molecular Envelope Technology (MET)
MECHANISM OF ACTIONHighly purified pharmaceutical-grade cannabidiol (CBD), approved in the United States, has demonstrated efficacy with an acceptable safety profile in patients with Lennox-Gastaut or Dravet syndrome. CBD acts on cannabinoid (CB) receptors of the endocannabinoid system, which are found in numerous body areas, including the peripheral system and the central nervous systems, including the brain. The endocannabinoid system regulates many physiological responses of the body and neuronal excitability responses relevant to the pathophysiology of many disease types, including epilepsy.
Virpax will pursue FDA Fast Track as an Orphan Disease New Chemical Entity (NCE)