Oragenics Creates Automated Intranasal Device for Concussion Treatment

Oragenics, Inc., a company based in Sarasota, Florida, and listed on the NYSE American as OGEN, has announced the completion of a prototype for an automated intranasal device. This device is designed for use in patients who have suffered a concussion and are in an acute phase where they may be confused, dazed, or unconscious. The primary goal of this development is to provide a reliable means of administering their lead drug candidate, ONP-002, to patients who cannot follow instructions for drug administration due to their condition.

ONP-002 is a newly developed chemical entity aimed at treating neurological disorders by targeting the brain through nasal delivery. The delivery mechanism involves introducing the drug into the nasal cavity, from where it travels to the brain. The company is preparing to conduct a Phase II clinical trial to evaluate the drug's effectiveness, focusing on blood biomarkers and patient-reported outcomes among those who have suffered concussions.

One of the significant challenges faced by patients with concussions is the loss of consciousness and acute memory impairment, which are closely associated with prolonged post-concussion symptoms and adverse clinical outcomes. Oragenics' intranasal device is breath-propelled, requiring the patient to blow the drug into their nose. However, this method poses difficulties for patients with severe mental impairment or unconsciousness. Therefore, the company has developed an automated prototype to be used by medical staff for the initial treatment of such patients in the acute phase. This device aims to ensure that the drug can be administered effectively even when the patient cannot actively participate in the process.

Michael Redmond, President of Oragenics, expressed optimism about the new automated technology, highlighting its potential to treat a wide range of concussive injuries. He noted that both the breath-propelled and automated devices offer unique advantages and can deliver the nanoparticle powder form of ONP-002. The primary aim is to improve clinical outcomes for concussed patients by providing the most effective drug delivery route, especially in the early stages of mental alteration post-injury.

Statistics indicate that approximately 10% of concussed patients experience a loss of consciousness, while a significant number display immediate altered mental states, including short-term memory loss and confusion. These conditions are linked to extended post-concussion symptoms and poor clinical results. Concussions represent a significant unmet medical need, with an estimated 69 million cases reported annually worldwide. Common causes include falls, motor vehicle accidents, and contact sports. Additionally, concussions are associated with other neurological disorders such as Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE). Post-concussion symptoms often lead to long-term disability, affecting up to 20% of those with concussions.

Oragenics is committed to addressing this widespread issue by advancing the development of ONP-002 and its delivery systems. The upcoming Phase II trial is a crucial step in validating the efficacy of their treatment approach and potentially providing a much-needed solution for concussion management and its associated complications.