• Enrollment underway at Mackay Base Hospital in Queensland, Australia; additional sites in final activation stages
SARASOTA, Fla., April 20, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE:OGEN), a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology, today announced that 2 patients and 8 study drug doses have been administered in its ongoing Phase IIa clinical trial evaluating ONP-002, the Company's lead candidate for the treatment of mild traumatic brain injury (mTBI) a.k.a., concussion. Enrollment is progressing at Mackay Base Hospital in Queensland, Australia, the first activated site in the trial, with additional sites completing final activation steps.
Traumatic brain injury represents a significant neurological condition without an FDA-approved pharmacological treatment. According to the CDC, an estimated 1.7 to 3.8 million people in the U.S. experience traumatic brain injuries annually, with sports and recreational activities among the leading causes. Globally, an estimated 69 million individuals sustain traumatic brain injuries each year. Despite this scale, no pharmacological treatments have been approved — leaving patients, military personnel, athletes, and families without FDA-approved effective options beyond rest and symptom management. If approved by the FDA, ONP-002 would be the first and only pharmacological standard of care for a global concussion market projected to reach over $9 billion by 2030.