Oragenics Enhances Intranasal Drug for Concussion Treatment

Oragenics, Inc. (NYSE American: OGEN) has announced the development of a new formulation for its neurosteroid, ONP-002, aimed at treating concussions. This unique intranasal pharmaceutical is designed to rapidly deliver the drug to the brain via the nasal cavity. A Phase II clinical trial is being planned to evaluate the safety and effectiveness of ONP-002, with a focus on patient blood biomarker profiles and functional outcomes.

The company believes that the nasal cavity offers a quick route for the neurosteroid to reach the brain, addressing the challenge of getting neurosteroids into solution. The improved formulation is expected to significantly increase the final dose levels, enhance intranasal adhesion, and allow for longer absorption times.

Oragenics' enhanced drug formulation aims to reduce the initial symptoms of concussion and prevent long-term debilitating effects. Dr. James Kelly, Chief Medical Officer at Oragenics, expressed excitement about the new formulation, emphasizing the potential to provide better chemical protection to the brain during the acute phase of a concussion.

Concussions are a significant unmet medical need, with an estimated 69 million cases reported annually worldwide. They can result from falls, motor vehicle accidents, military incidents, and contact sports. Long-term consequences of concussions can include neurological disorders such as Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE). Approximately 20% of concussed patients suffer from long-term symptoms leading to disability.

Oragenics is a development-stage biotechnology company focusing on nasal delivery of pharmaceutical treatments for neurological disorders and infectious diseases. Their product pipeline includes treatments for mild traumatic brain injury (concussion) and Niemann Pick Disease Type C (NPC), along with proprietary intranasal formulations and devices for drug delivery.