Oragenics Gears Up for Phase II Concussion Drug Trials

Oragenics, Inc., a company specializing in the development of innovative intranasal pharmaceuticals for neurological disorders, is advancing its drug candidate, ONP-002, towards a Phase IIA clinical trial. This novel drug is designed to address mild Traumatic Brain Injury (TBI), commonly known as concussion, and is anticipated to be used in conjunction with a unique intranasal device.

ONP-002 is a new chemical entity that targets the brain via a self-propelled powdered delivery system through the nasal cavity. A Phase I study involving 40 human participants demonstrated the safety and tolerability of ONP-002. The company is currently in the process of manufacturing the Active Pharmaceutical Ingredient (API), which will then be formulated into a nanoparticle powder. This powder will be loaded into an innovative intranasal device that is breath-propelled, potentially enhancing the drug's binding to the olfactory nerve beds for direct delivery to the brain.

The intranasal delivery method for ONP-002 has shown to increase brain exposure and metabolism in animal studies. Michael Redmond, President of Oragenics, expressed enthusiasm for the upcoming Phase II study, highlighting the importance of early treatment for concussion patients when the pathological process is most active. Recruitment for the Phase II trial will target patients aged between 18 and 55 who have recently experienced a concussion.

Concussions represent a significant unmet medical need, with approximately 69 million cases reported globally each year. Causes range from falls and motor vehicle accidents to contact sports. Concussions have also been linked to other neurological disorders such as Alzheimer's, Parkinson's, and Chronic Traumatic Encephalopathy (CTE). Post-concussion syndrome can lead to long-term disability in up to 20% of affected individuals.

Greg Gironda, an Operational Consultant at Oragenics, emphasized the importance of manufacturing and formulating the API in a Good Manufacturing Practice (GMP) facility to ensure the drug's integrity throughout the trial process. The company is looking forward to completing this phase and initiating the Phase II trial in the near future.

The development of ONP-002 and its associated intranasal device represents a significant step forward in the treatment of mild TBI. With the potential to provide early intervention for concussion patients, Oragenics' approach could offer a much-needed solution to a widespread and serious medical issue.