Oragenics, Inc. Announces Regulatory Approval To Begin Phase II Concussion Drug Study In Australia

Oragenics, Inc., a biotechnology company developing intranasal therapies for brain-related conditions, has received approval from the Human Research Ethics Committee (HREC) in Australia to begin a Phase II clinical trial of its lead drug candidate, ONP-002, for treating mild traumatic brain injury (mTBI), commonly known as concussion. This approval allows Oragenics to expand its clinical efforts internationally and move forward with studies in Australia. Patient enrollment could begin as early as the second quarter of 2025. The trial will be conducted in level 1 trauma emergency departments, where patients with concussions typically receive care after incidents like car accidents, falls, or sports injuries.

Janet Huffman, Chief Executive Officer of Oragenics, said in a statement, "Receiving HREC approval in Australia brings us one step closer to offering a much-needed therapeutic option for patients suffering from concussions. With enrollment sites considered in both Australia and New Zealand, we are significantly expanding the geographic footprint of our ONP-002 program as we move this critical drug trial forward.”

ONP-002 is a neuroprotective therapy administered through the nose, offering a simple, non-invasive method to deliver treatment directly to the brain. In earlier lab studies, the drug reduced inflammation, oxidative stress, and brain swelling key issues in concussion. Results from a Phase I trial showed that ONP-002 was safe and well-tolerated. With this trial, Oragenics is taking a major step toward developing a new acute treatment option for concussions, a condition that affects millions of people worldwide.