Oragenics, Inc. announced it is preparing for a Phase II clinical trial using its novel drug - device combination for the treatment of mild Traumatic Brain Injury, aka concussion. Oragenics? lead drug candidate, ONP-002, is a new chemical entity (NCE) designed to target the brain through self-propelled powdered delivery into the nasal cavity.

A 40-patient Phase I study showed ONP-002 to be safe and well-tolerated. Oragenics has begun the final process of synthesizing and formulating the drug needed for its Phase II clinical trial. It is expected that enrolled patients will be in the acute phase following concussions, after diagnosis the patient will quickly receive their first dose intranasally.

ONP-002 has been shown to have a neuroprotective molecular profile and improve behavioral outcomes including memory and motor performance in animal models of brain injury. The drug has a large safety margin between dosages used in the animal toxicology program and those used in the Phase I study and planned for the upcoming Phase II clinical trial. Intranasal delivery of ONP-002 as a nanoparticle has been shown to enhance brain exposure in animals.

Concussion is an unmet medical need. There is an estimated 69M concussions annually reported worldwide. Common causes of concussion include falls, motor vehicle accidents and contact sports.

Other neurological disorders including Alzheimer?s Disease, Parkinson?s Disease and Chronic Traumatic Encephalopathy (CTE) have been linked to concussion. Post concussion syndrome is linked to long term disability and occurs in as high as 20% of concussed patients.