Oragenics Doses First Patient In Phase IIa Trial Of ONP-002, Its Intranasal Therapy For Concussion And Mild Traumatic Brain Injury

Oragenics, Inc., a clinical-stage biotechnology company focused on developing brain-targeted therapies using its proprietary intranasal delivery technology, has announced that the first patient has been dosed in its Phase IIa clinical trial evaluating ONP-002. This investigational drug is the company’s lead candidate for the treatment of concussion, also known as mild traumatic brain injury (mTBI). The milestone was reached at Mackay Hospital in Australia, which became the first active site in the trial shortly after its activation on March 31, 2026.

Concussion is one of the most common neurological conditions worldwide, yet there are currently no FDA-approved drug treatments available. According to estimates from the Centers for Disease Control and Prevention (CDC), between 1.7 and 3.8 million people in the United States experience traumatic brain injuries each year, often due to sports and recreational activities. Globally, around 69 million people are affected annually. Despite the scale of the issue, current care is largely limited to rest and symptom management. If approved, ONP-002 could become the first pharmacological treatment for concussion, addressing a significant unmet medical need in a global market projected to exceed $9 billion by 2030.

The initiation of patient dosing follows approval from Australia’s Human Research Ethics Committee (HREC) and the activation of Mackay Hospital as the first clinical site. The rapid enrollment of an eligible patient shortly after site activation highlights both the urgency and the widespread nature of the need for effective treatments in this area. Additional sites, including Alfred Hospital in Melbourne and Royal Adelaide Hospital in Adelaide, are currently progressing through regulatory and governance approvals, with activation expected in the second quarter of 2026.

ONP-002 is a first-in-class intranasal neurosteroid designed to target the underlying biological effects of brain injury. Unlike existing approaches that focus on managing symptoms, this therapy aims to reduce neuroinflammation, oxidative stress, and brain swelling (cerebral edema). By addressing the root causes of injury, ONP-002 has the potential to shift concussion treatment toward active neurological intervention. The drug is delivered using Oragenics’ proprietary intranasal spray-dry powder device, aligning with the growing nasal drug delivery market, which is expected to reach nearly $93 billion by 2030.

Chief Executive Officer Janet Huffman emphasized that the company has moved quickly from site activation to patient dosing, reinforcing its commitment to execution and innovation. She noted that the immediate availability of an eligible patient reflects the reality that millions of people currently have no effective treatment options for concussion. Huffman stated that the company aims to change that by advancing a therapy that could meaningfully improve patient care.

Chief Medical Officer Dr. James Kelly added that the positive safety results from the Phase 1 trial provided confidence to move into the next stage of development. He also highlighted the importance of the HREC approval process, which ensures that clinical trials meet strict safety and ethical standards. Drawing on his clinical experience, Dr. Kelly emphasized that ONP-002 represents a fundamentally different approach by targeting the injury itself rather than just treating symptoms, marking an important step forward in concussion research and care.