Oragenics, Inc. announced it is preparing to undertake the final steps of GMP manufacturing and formulation of its drug candidate for its expected Phase IIA clinical trial. The drug candidate is expected to be combined with its novel intranasal device, 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 and onward to the brain.

A 40-patient Phase I human study showed ONP-002 to be safe and well-tolerated. Oragenics is currently manufacturing the Active Pharmaceutical Ingredient (API) that will then be formulated and spray dried as a nanoparticle powder. Once formulated the powder is loaded into an intranasal device, believed to be novel, that is breath-propelled, which Oragenics believes will improve intranasal binding to the olfactory vein beds for delivery directly to the brain.

This application, believed to be novel, is designed as an acute field deliverable, intended to allow for concussed patients to get treatment in the early stages when the pathological cascade is most intense. 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. "Concussions can have serious long-term consequences.

Manufacturing and formulating API in a GMP facility ensures the integrity of the drug before and during the trials, the company look forward to completing this work in the short-term and getting the Phase II trial underway.