Oragenics Advances ONP-002 Toward Phase 2 Trials For Mild Traumatic Brain Injury mTBI

Oragenics, Inc., a clinical-stage biotechnology company focused on brain-targeted therapies delivered through proprietary intranasal technology, has outlined its key development goals for 2026. The company is advancing its lead program, ONP-002, an investigational intranasal neurosteroid being studied as a potential first-in-class pharmacological treatment for concussion and mild traumatic brain injury (mTBI).

ONP-002 is designed to rapidly transport drug molecules directly to the brain through the nasal cavity, aiming to reduce inflammation, oxidative stress, and neuronal damage shortly after injury, an important factor in concussion care where early intervention is critical.

Oragenics’ CEO Janet Huffman commented, “Through successful operational, regulatory and financial execution over the past year, we achieved key strategic milestones that secured the clinical infrastructure required to enter a Phase 2 clinical trial of ONP-002 in Australia this year. We have demonstrated financial discipline and transparency in support of our clinical development program, and the Company is now well-positioned to advance ONP-002 toward meaningful value-creating milestones.

“We remain deeply committed to delivering a much-needed therapeutic solution for patients suffering from concussion and mTBI. Based on positive pre-clinical and Phase 1 clinical safety and efficacy data with no competition in the clinic to date, ONP-002, if approved, shows potential to become the first commercial treatment for a projected $9 billion global concussion market.”

Concussion and mTBI remain among the most common neurological conditions without an FDA-approved therapy. In the United States alone, traumatic brain injuries affect more people annually than stroke, Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, and ALS combined. CDC estimates indicate that 1.7 to 3.8 million Americans experience TBIs each year, often due to sports or recreational accidents. The global concussion treatment market is forecast to exceed USD 9 billion by 2030, while the broader nasal drug-delivery market could approach USD 93 billion over the same period.

Oragenics has submitted the necessary regulatory and ethics applications to initiate its Phase 2 clinical program, although site activation is being coordinated with a major hospital consolidation in Australia, where five Victoria-based hospitals are merging to form Bayside Health.

Huffman noted, “As a result of the hospital consolidations in Australia, the merged entity is likely to prioritize certain internal organizational and governance steps in the near term. This process has delayed final verification of our HREC approval for the Phase 2a trial, extending our clinical site onboarding and patient dosing several months beyond our prior target.”

The company’s Phase 2a study is a randomized, placebo-controlled trial enrolling 40 patients diagnosed with concussion based on CT scans, symptoms, and hospital or emergency room admission. Participants will receive their first dose within 12 hours of injury, followed by treatment and monitoring for up to 30 days. Primary assessments will focus on safety and tolerability through nasal exams, physical evaluations, and neurocognitive testing, while feasibility will be judged by treatment compliance and patient tolerance.