Oragenics, Inc. announced on May 13, 2025, that it received approval from the Human Research Ethics Committee (HREC) in Australia to initiate its Phase II clinical trial. This trial will evaluate ONP-002 for the treatment of mild traumatic brain injury (mTBI), also known as concussion.
This approval marks a significant milestone, allowing Oragenics to initiate clinical trials in Australia and potentially begin patient enrollment as early as the second quarter of 2025. Enrollment and treatment administration are expected to occur in level 1 trauma emergency departments.
CEO Janet Huffman stated that HREC approval brings the company closer to offering a much-needed therapeutic option for concussion patients. Expanding the geographic footprint of the ONP-002 program to Australia and New Zealand is a key step in advancing this critical drug trial.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.