$Oragenics (OGEN.US)$ Oragenics, Inc. (NYSE American: OGEN) ...

$Oragenics (OGEN.US)$ Oragenics, Inc. (NYSE American: OGEN) Announces Concussion Drug, ONP-002, Successfully Clears FDA-Required Cardiotoxicity Testing - 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. 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.

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.

"We are pleased that ONP-002 has demonstrated a strong safety margin for the heart, enabling us to continue planning the Phase II trials. Safety remains our top priority, and we will continuously monitor all safety parameters throughout the trials," stated Michael Redmond, President of Oragenics. "Furthermore, a Phase II study is being planned to further evaluate the drug in concussed patients."

Concussion is a significant unmet medical need, with an estimated 69 million cases reported annually worldwide. Common causes of concussions include falls, motor vehicle accidents, and contact sports. According to the CDC, the total annual healthcare cost for nonfatal traumatic brain injuries (TBIs) exceeds $40.6 billion. This includes $10.1 billion covered by private insurance, $22.5 billion by Medicare, and $8 billion by Medicaid. Concussions have been associated with other neurological disorders, such as Alzheimer's Disease, Parkinson's Disease, and Chronic Traumatic Encephalopathy (CTE). Additionally, post-concussion symptoms, which can occur in up to 20% of affected individuals, are linked to long-term disability. CONTINUED… Read this full press release and more news for Oragenics at: https://www.oragenics.com/news-media/press-releases