Oragenics (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, announced that its lead candidate for treating concussion, ONP-002, does not cause DNA damage and genotoxicity in an animal model. According to the announcement, the company completed a study evaluating ONP-002, a new chemical entity (“NCE”) designed to target the brain through delivery into the nasal cavity and onward to the brain. Testing on cells and animals to ensure a substance does not cause damage affecting cell division is required by the U.S. Food and Drug Administration prior to conducting a clinical trial.
“We continue to be pleased with the safety profile of ONP-002,” said Oragenics president Michael Redmond in the press release. “We have now shown a safety margin in our two-species toxicology program, cardiac safety with GLP hERG testing and no issue with cancer-causing DNA damage using the in vivo micronucleus assay. Oragenics strongly believes that ONP-002 will be safe for concussed patients in our planned phase 2 clinical trial. We will continue to monitor systemic and intranasal safety parameters throughout the drug-development program.”
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About Oragenics Inc.
Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases, including drug candidates for treating mild traumatic brain injury, also known as concussion, and for treating Niemann Pick Disease Type C (“NPC”), as well as proprietary powder formulation and an intranasal delivery device. For more information about the company, please visit www.Oragenics.com.
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