$Oragenics (OGEN.US)$ $Oragenics (OGEN.US) $ Oragenics, Inc....

$Oragenics (OGEN.US)$ $Oragenics (OGEN.US) $ Oragenics, Inc. (NYSE: OGEN) announced that the concussion drug ONP-002 successfully passed the cardiotoxicity test required by the US Food and Drug Administration — Oragenics, Inc., a company focused on developing unique intranasal drugs for treating neurological diseases, announced that it has successfully completed a study showing that ONP-002 does not cause cardiotoxicity. ONP-002 is a new chemical entity (NCE) designed to target the brain by being delivered to the nasal cavity and continuing to the brain. Prior to clinical trials, the US Food and Drug Administration (FDA) requires drugs to be tested on cardiac receptors to ensure they don't show any cause of electrical malformations.

Oragenics performed a HERG (human Ether-a-Go-GO related gene) ion channel study on ONP-002 according to Charles River Laboratory's Good Laboratory Practice (GLP). As with previous non-GLP hERG studies, inhibitory concentrations were greater than 10 micromoles. Based on the dose from the Phase 1 ONP-002 clinical trial and subsequent plasma concentrations, it is expected that there will be a large margin of cardiac safety for ONP-002, which indicates that the treatment of concussions with ONP-002 does not cause arrhythmia.

“We are pleased that ONP-002 shows a strong margin of cardiac safety, allowing us to continue planning phase II trials. Safety remains our top priority, and we will continue to monitor all safety parameters throughout the testing process.” said Michael Redmond, president of Oragenics. “Additionally, a phase II study is being planned to further evaluate the use of the drug in patients with concussions.”

Concussions are a major unmet medical need, with an estimated 69 million cases reported globally each year. Common causes of concussions include falls, motor vehicle accidents, and contact exercise. According to the Centers for Disease Control and Prevention, total annual medical expenses for non-fatal traumatic brain injury (TBI) exceed $40.6 billion. This includes $10.1 billion for private insurance coverage, $22.5 billion for Medicare coverage, and $8 billion for Medicaid. Concussions are linked to other neurological disorders, such as Alzheimer's disease, Parkinson's disease, and chronic traumatic encephalopathy (CTE). Furthermore, possible post-concussion symptoms in as many as 20% of those affected are linked to long-term disability. Continued... Read the full Oragenics press release and more news at: https://www.oragenics.com/news-media/press-releases
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