Oragenics Inc. Announces Concussion Drug, ONP-002, Successfully Clears FDA-Required Cardiotoxicity Testing

The potential addressable market opportunity for ONP-002 includes an estimated 69 million concussions globally

UF Innovate | Accelerate graduate Oragenics, Inc., a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, announced its lead candidate for treating concussion successfully completed a study that indicates ONP-002 does not cause cardiotoxicity. It also completed a study that indicates it does not cause DNA damage and genotoxicity in an animal model.

ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. Prior to conducting a clinical trial, the U.S. Food and Drug Administration (FDA) requires pharmaceuticals to be tested on cardiac receptors to ensure that they do not show any causes of electrical malformations. It also requires pharmaceuticals be tested on cells and animals to ensure they do not cause damage affecting cell division.

Oragenics conducted hERG (human Ether-à-go-go-Related Gene) ion channel studies on ONP-002 under Good Laboratory Practices (GLP) with Charles River Laboratories. Like previous non-GLP hERG studies, inhibitory concentrations were greater than 10 micromolar. Based on Phase I ONP-002 clinical trial dosing and subsequent blood plasma concentrations, ONP-002 is expected to have a large cardiac safety margin, suggesting that ONP-002 treatment for concussion will not cause cardiac arrhythmia.

It also conducted an in vivo (animal) study to determine if multi-day treatments of ONP-002 cause DNA damage and increased risk of cancer. Three concentrations of ONP-002 were used at a low, medium, and high dose. Animal bone marrow was dissected and analyzed for DNA damage. The results showed no evidence of genetic mutations, suggesting that ONP-002 does not affect the cell cycle and therefore does not disrupt cell division that could be cancer-causing. Oragenics partnered with VivoPharm, Inc. to conduct this study under Good Laboratory (GLP) conditions. These results suggest that multi-day treatment for concussion using ONP-002 will not cause genotoxicity.

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