Oragenics Inc. (NYSE American: OGEN) activated Alfred Hospital as the second site in its Phase IIa clinical trial of ONP-002 for concussion and mild traumatic brain injury treatment. The biotechnology company reported that four patients have been enrolled and dosed at Mackay Base Hospital in Queensland, Australia, the first activated site since March 31.

The Phase IIa trial plans to enroll 40 patients who meet specific criteria based on CT scan findings, symptoms, and emergency room or hospital admission. Patients receive initial dosing within 12 hours of concussion, followed by treatment for up to 30 days. ONP-002 is administered through the company's proprietary intranasal spray-dry powder device.

ONP-002 is an investigational neurosteroid designed to reduce neuroinflammation, oxidative stress, and cerebral edema following brain injury. The drug candidate completed Phase I clinical trials with no serious adverse events reported across all dose levels.

The company projects clinical data readout before the end of 2026 and plans to submit an investigational new drug application to the FDA by December 31, 2026, for a Phase IIb trial in the United States.

"Four patients have been dosed at Mackay Base Hospital in less than a month of activation," said Janet Huffman, Oragenics CEO. "Two sites are now actively enrolling, and we intend to maintain this pace through the full 40-patient enrollment."

According to the CDC, an estimated 1.7 to 3.8 million people in the U.S. experience traumatic brain injuries annually. No FDA-approved pharmacological treatments currently exist for concussion and mild traumatic brain injury.