On Friday, Oragenics, Inc. (NYSE: OGEN) received a significant boost in investor confidence following the regulatory approval for its lead drug candidate, ONP-002. This positive development propelled OGEN shares to a notable $1.40, marking a substantial increase of 29.63%.
Successful Study Results for ONP-002
Oragenics (OGEN) announced that ONP-002, its principal therapeutic candidate, had finished a trial showing no cardiotoxicity. A brand-new chemical compound called ONP-002 is intended to enter the nasal passage and go straight to the brain to give medicinal benefits.
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The U.S. Food and Drug Administration (FDA) requires medications to be tested for potential cardiac problems in order to avoid electrical abnormalities prior to clinical trials. The business worked with Charles River Laboratories to undertake hERG (human Ether-à-go-go-Related Gene) ion channel tests on ONP-002, all while abiding by Good Laboratory Practices (GLP).
The results showed that inhibitory concentrations remained above 10 micromolar, consistent with prior non-GLP studies. Based on Phase I clinical trial data and blood plasma concentrations, ONP-002 is projected to have a substantial cardiac safety margin, suggesting minimal risk of cardiac arrhythmia.
Addressing a Critical Medical Need
Oragenics has noted that ONP-002 demonstrates a strong cardiac safety profile, allowing the company to proceed with Phase II trials. Ensuring patient safety remains a top priority, and the company will maintain rigorous monitoring throughout the study.
The upcoming Phase II trial aims to further assess ONP-002’s efficacy in treating concussions. A significant worldwide health issue, concussions account for over 69 million instances each year.
Contact sports, falls, and collisions with moving cars are the main causes of these injuries. The annual treatment expenses for nonfatal traumatic brain injuries—including private insurance, Medicare, and Medicaid payments—are estimated by the Centers for Disease Control and Prevention (CDC) to be over $40.6 billion.
Concussions have been linked to a considerable number of neurological conditions, such as Alzheimer’s disease, Parkinson’s disease, and chronic traumatic encephalopathy (CTE).
