Announcement • May 07
Oragenics Inc Activates Second Site In Phase IIa Clinical Trial of ONP-002 for Concussion and Mild Traumatic Brain Injury Oragenics, Inc. announced that Alfred Hospital is now actively enrolling participants in its ongoing Phase IIa clinical trial evaluating ONP-002, the Company’s lead candidate for the treatment of concussion and mild traumatic brain injury (mTBI). To date, four patients have been enrolled and dosed at Mackay Base Hospital in Queensland, Australia, the first site activated in the trial. Concussion and mild traumatic brain injury represent the most prominent 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. 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. The Company’s Phase IIa trial is designed to enroll 40 patients who meet enrollment criteria based on CT scan findings, presenting symptoms, and emergency room or hospital admission. Patients receive first dosing within 12 hours of concussion, followed by continued treatment for up to 30 days. The pace of enrollment at Mackay Base Hospital since site activation on March 31, 2026, reflects both strong site readiness and the depth of unmet clinical need in this patient population. ONP-002 is delivered via Oragenics’ proprietary intranasal spray-dry powder device. ONP-002 is a first-in-class intranasal neurosteroid designed to address the underlying biology of brain injury — reducing neuroinflammation, oxidative stress, and cerebral edema — rather than simply managing symptoms. The drug candidate targets the biological cascade triggered by trauma, with the potential to represent a paradigm shift from symptom management to active neurological intervention. The Phase IIa clinical data readout is projected before year-end 2026, and is expected to support the Company’s planned investigational new drug (IND) application submission to the FDA, targeting December 31, 2026, for a Phase IIb clinical trial in the U.S. ONP-002 is an investigational neuroprotective, anti-inflammatory intranasal drug candidate targeting mild traumatic brain injury (mTBI) and concussion. Designed to interrupt biological pathways involved in inflammation, oxidative stress, and swelling following head trauma, ONP-002 has demonstrated safety and tolerability in Phase I clinical trials with zero serious adverse events across all dose levels. The drug candidate utilizes Oragenics’ proprietary intranasal delivery platform to enable rapid, targeted brain delivery — potentially representing a paradigm shift from symptom management to active neurological intervention. Oragenics is advancing ONP-002 through Phase IIa clinical trials in Australia, with U.S. Phase IIb trials planned to follow pending FDA investigational new drug application (IND) approval. 
