Oragenics Administers Eight ONP-002 Doses as Trial Targets $9 Billion Concussion Market
Oragenics administered eight ONP-002 doses to two mild TBI patients in its Phase IIa trial at Mackay Base Hospital in Queensland, with additional Australian sites finalizing activation. The trial targets enrollment of 40 patients receiving intranasal ONP-002 to reduce neuroinflammation and edema, targeting a $9 billion concussion market by 2030.
1. Phase IIa Trial Progress
Oragenics has activated Mackay Base Hospital in Queensland as its first Phase IIa trial site, where two patients have received eight ONP-002 doses to date. Additional Australian sites are completing final activation steps to support enrollment of up to 40 patients, each dosed within 12 hours of injury.
2. ONP-002 Candidate Profile
ONP-002 is a first-in-class intranasal neurosteroid delivered via the company’s proprietary spray-dry powder device, designed to target neuroinflammation, oxidative stress and edema following concussion. Phase I trials demonstrated strong safety and tolerability, with zero serious adverse events across all dose levels.
3. Market Potential
Traumatic brain injury affects an estimated 69 million people globally each year, including 1.7 to 3.8 million U.S. cases, and currently lacks FDA-approved pharmacological treatments. The global concussion market is projected to exceed $9 billion by 2030, positioning ONP-002 for potential first-to-market advantage.
4. Next Steps
Enrollment will expand to Alfred Hospital in April and continue until 40 participants are dosed and followed for up to 30 days. Pending FDA IND approval, Oragenics intends to launch U.S. Phase IIb trials to advance ONP-002 toward regulatory submission.