Oragenics, Inc. Announces Approval To Initiate Phase II Concussion Drug Trial in Australia

UF Innovate | Accelerate graduate Oragenics, Inc., a biotechnology company focused on developing novel intranasal therapies for brain-related disorders, announced that it has received approval from the Human Research Ethics Committee (HREC) in Australia to initiate its Phase II clinical trial evaluating ONP-002, the Company’s proprietary neuroprotective therapy, for the treatment of mild traumatic brain injury (mTBI), aka concussion.

This approval marks a significant milestone in expanding Oragenics’ clinical development efforts internationally. With this clearance, Oragenics can initiate clinical trials in Australia and could begin patient enrollment as early as the second quarter of 2025. Once the Company is prepared to commence enrollment, patient enrollment and treatment administration is expected to occur in level 1 trauma emergency departments where concussed patients are often seen following motor vehicle accidents, falls, and contact sports.

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