Oragenics has activated a second site for its ongoing Phase IIa clinical trial of ONP-002, its lead treatment candidate for concussion and mild traumatic brain injury (mTBI).
The site, Alfred Hospital, is currently enrolling participants for the study.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Four patients have already been enrolled and received ONP-002 doses at Mackay Base Hospital in Queensland, Australia, the first activated centre.
The Phase IIa trial aims to enrol 40 patients using criteria based on CT scan results, symptoms, and emergency room or hospital admission.
Patients receive their first dose within 12 hours of concussion and continue treatment for up to 30 days.
Since site activation in March 2026, enrolment at Mackay Base Hospital has demonstrated strong readiness and underlying clinical need for effective mTBI therapies.
ONP-002 is administered via Oragenics’ intranasal spray-dry powder device. It is described as a first-in-class intranasal neurosteroid intended to target the biological cascade following brain trauma.
The therapy aims to reduce neuroinflammation, oxidative stress, and cerebral oedema to actively intervene in the brain injury process.
Oragenics anticipates clinical data readout by year-end 2026, which will support the planned new drug application to the US Food and Drug Administration (FDA), aiming for the Phase IIb trials by December 2026.
Oragenics CEO Janet Huffman said: “We are executing against our clinical plan. Two sites are now actively enrolling, and we intend to maintain this pace through the full 40-patient enrolment. For the millions of people who have been told there is nothing that can be done for concussion, we are here to prove otherwise.”
ONP-002 has demonstrated tolerability and safety in Phase I studies, with no serious adverse events reported at any dose.
Oragenics continues to advance ONP-002 through Phase IIa trials in Australia.
