Oragenics said that it has initiated a Phase 2a trial of ONP-002, a dry powder intranasal neurosteroid, for the treatment of mild traumatic brain injury in Australia after receiving approval from the Human Research Ethics Committee. In March 2025, the company announced that it had submitted an application to Australian authorities for permission to conduct a Phase 2 trial of ONP-002.
According to Oragenics, the placebo-controlled Phase 2a trial is expected to enroll 40 patients who arrive in emergency departments for treatment of concussion, with the first dose administered within 12 hours of the injury and treatment continuing for up to 30 days. The company says that the trial will evaluate factors such as patient compliance, tolerability, and safety.
Assuming that the trial is successful, Oragenics says that it plans to submit an IND to the FDA by the end of this year for clinical trials in the US. The company acquired ONP-002 from Odyssey Health in 2023; Odyssey had acquired the product (formerly PRV-002) from Prevacus in 2021.
Oragenics Chief Medical Officer James Kelly said, “The Phase 1 safety profile gave us strong scientific confidence entering this next phase. The HREC process is rigorous by design; it exists to protect patients, and receiving that clearance confirmed that our trial design, safety protocols, and investigator teams meet the highest standards. As a clinician who has worked with concussion patients for decades, this moment is deeply meaningful. ONP-002 targets the injury itself, not just the symptoms. That is a fundamentally different approach to concussion care, and we are now putting it to the test in patients.”
CEO Janet Huffman commented, “We said we would dose our first patient in Australia, and we have. Mackay Hospital was active for only a matter of days before an eligible patient presented, and that immediacy is not a coincidence. It reflects the reality of what we have always said: there is no pharmacological treatment for concussion, and patients and clinicians are ready for something new. . . . For the millions of people who suffer concussions every year and are told there is nothing that can be done, we are here to change that.”
Read the Oragenics press release
