Oragenics' Concussion Drug ONP-002 Passes FDA Cardiotoxicity Test

Oragenics, Inc. (NYSE American: OGEN), a company dedicated to developing unique intranasal pharmaceuticals for neurological disorders, recently announced a significant milestone for its leading candidate, ONP-002. The company reported that ONP-002, designed for treating concussions, successfully completed a study demonstrating that it does not cause cardiotoxicity. This new chemical entity (NCE) aims to target the brain by delivering the drug through the nasal cavity directly to the brain. Before proceeding to clinical trials, the U.S. Food and Drug Administration (FDA) mandates that new pharmaceuticals be tested on cardiac receptors to ensure they do not cause electrical malformations.

Oragenics performed hERG (human Ether-à-go-go-Related Gene) ion channel studies on ONP-002 under Good Laboratory Practices (GLP) with Charles River Laboratories. The results mirrored previous non-GLP studies, showing that inhibitory concentrations exceeded 10 micromolar. Based on the dosing in the Phase I clinical trial and subsequent blood plasma concentrations, ONP-002 is anticipated to have a significant cardiac safety margin, suggesting it will not cause cardiac arrhythmia when used to treat concussions.

Michael Redmond, President of Oragenics, expressed satisfaction with the findings, stating, "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." He also mentioned that a Phase II study is being planned to further evaluate the drug in patients with concussions.

Concussions represent a major unmet medical need, with approximately 69 million cases reported globally each year. Common causes include falls, motor vehicle accidents, and contact sports. According to the Centers for Disease Control and Prevention (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 are associated with other neurological disorders such as Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE). Additionally, up to 20% of affected individuals experience post-concussion symptoms, which are linked to long-term disability.

Oragenics is a biotechnology company in its development stage, focusing on nasal delivery of pharmaceutical medications for neurological conditions and fighting infectious diseases. The company's drug candidates include treatments for mild traumatic brain injury (mTBI), also known as concussion, and Niemann Pick Disease Type C (NPC). They also offer a proprietary powder formulation and an intranasal delivery device for their pharmaceuticals.

In summary, Oragenics' ONP-002 has shown promising results in terms of cardiac safety, paving the way for future clinical trials. The company remains committed to addressing the significant medical need for effective concussion treatments while ensuring the highest safety standards. As they move forward, the planned Phase II trials will be crucial in further evaluating ONP-002's efficacy in treating concussed patients.