Oragenics' Concussion Drug Passes FDA Genotoxicity Study

Oragenics, Inc., a biotechnology company headquartered in Sarasota, Florida, has announced a significant development concerning their lead candidate for concussion treatment, ONP-002. The company's latest study has confirmed that ONP-002 does not cause DNA damage or genotoxicity in animal models, an essential step before moving on to human clinical trials.

ONP-002 is a novel chemical entity specifically designed for targeting brain injuries through nasal delivery. This approach allows the drug to reach the brain more directly, potentially increasing its effectiveness in treating neurological disorders like concussion. Prior to receiving approval for clinical trials from the U.S. Food and Drug Administration (FDA), it is mandatory for new pharmaceuticals to undergo rigorous testing on cells and animal models to ensure they do not induce harmful effects such as DNA damage or interfere with cell division, which could lead to cancer.

Oragenics conducted an in vivo study to evaluate whether repeated doses of ONP-002 cause DNA damage. The drug was administered in three different concentrations: low, medium, and high. Post-treatment, the bone marrow of the animals was examined to identify any signs of genetic mutations. The study revealed no evidence of DNA damage, indicating that ONP-002 does not disrupt the cell cycle or cause genetic mutations that might lead to cancer. This study was carried out in partnership with VivoPharm, Inc. under Good Laboratory Practice (GLP) conditions, further ensuring the reliability of the results.

Michael Redmond, President of Oragenics, expressed satisfaction with the ongoing safety evaluations for ONP-002. The company has demonstrated a safety margin through their two-species toxicology program, cardiac safety tests, and the in vivo micronucleus assay for cancer-causing DNA damage. Redmond stated his confidence in the safety of ONP-002 for patients suffering from concussions, as they prepare for a Phase II clinical trial. He emphasized the company's commitment to continually monitoring both systemic and intranasal safety parameters throughout the drug's development.

Concussions represent a significant unmet medical need, with approximately 69 million cases reported globally each year. Common causes include falls, motor vehicle accidents, and contact sports. Long-term impacts of concussions can be severe, potentially contributing to neurological disorders such as Alzheimer's Disease, Parkinson's Disease, and Chronic Traumatic Encephalopathy (CTE). Additionally, up to 20% of concussed patients may experience long-term disability due to post-concussion symptoms.

Oragenics is a development-stage biotechnology firm dedicated to the nasal delivery of pharmaceutical treatments for neurological conditions and infectious diseases. Their pipeline includes drug candidates for mild traumatic brain injury, commonly known as concussion, and Niemann Pick Disease Type C (NPC). The company also boasts a proprietary powder formulation and an intranasal delivery device.

In summary, Oragenics' recent study on ONP-002 marks a significant milestone in the development of a safe and effective treatment for concussion. The positive safety profile paves the way for further clinical trials, bringing hope to millions affected by concussions worldwide. The company's ongoing commitment to rigorous safety monitoring and innovative delivery methods underscores their potential to make a substantial impact in the field of neurological treatments.