Oragenics Receives Ethics Approval for Phase IIa Concussion Trial in Australia

Oragenics Inc. (NYSE American: OGEN) announced it has received final Human Research Ethics Committee approval in Australia to begin its Phase IIa clinical trial evaluating ONP-002, its lead intranasal neurosteroid drug candidate for the treatment of concussion, also known as mild traumatic brain injury. With all regulatory approvals secured, the company has initiated clinical site onboarding at three locations in Australia, led by Bayside Health (Alfred Health), and expects to dose the first patient before the end of March. The randomized, placebo-controlled study will enroll 40 patients to evaluate safety, tolerability and feasibility of ONP-002, with data expected before year-end 2026 as the company prepares for a future investigational new drug application to support additional U.S. clinical trials.

The approval represents a critical milestone for Oragenics as it advances ONP-002 through clinical development. Concussion and mild traumatic brain injury represent significant unmet medical needs with limited treatment options currently available. The company's intranasal delivery approach offers a novel method for administering neurosteroids directly to the brain, potentially bypassing the blood-brain barrier and providing more targeted therapy. This trial marks the first clinical evaluation of ONP-002 specifically for concussion treatment, positioning the drug candidate as a potential first-in-class therapy for this condition.

The Phase IIa trial's design focuses on establishing the foundational safety and tolerability profile of ONP-002 in concussion patients. The study will provide preliminary data on the drug's feasibility and potential efficacy signals, which will inform the design of subsequent larger trials. The Australian ethics approval enables Oragenics to leverage the country's established clinical research infrastructure and regulatory framework for neurological studies. The company's progress in Australia sets the stage for planned U.S. Phase 2b trials, creating a pathway for global development of ONP-002.

Beyond concussion treatment, Oragenics' intranasal delivery platform has broader implications for neurological care. The technology demonstrates potential applications across multiple neurological conditions, including Parkinson's disease, Alzheimer's disease, PTSD, and anxiety disorders. The successful development of ONP-002 could validate the company's platform approach and open doors for treating other brain disorders that currently lack effective therapeutic options. The company maintains its corporate information at https://oragenics.com while investor updates are available through its newsroom at https://ibn.fm/OGEN.

The timing of this trial initiation comes as awareness of concussion-related health issues continues to grow across sports, military, and general populations. Current management of mild traumatic brain injury primarily focuses on symptom management and rest, with no FDA-approved pharmaceutical treatments specifically for concussion. ONP-002's development addresses this therapeutic gap by targeting the underlying neurological mechanisms of injury. The neurosteroid approach represents a biologically plausible intervention that could modify the course of recovery following concussion, potentially reducing long-term complications and improving patient outcomes.

Oragenics' progress with ONP-002 reflects the growing recognition of neurosteroids as promising therapeutic agents for brain disorders. The company's clinical strategy demonstrates a methodical approach to drug development, beginning with safety and feasibility studies before advancing to larger efficacy trials. The Australian ethics approval represents not just regulatory clearance but also validation of the trial's scientific merit and ethical standards. As the company moves forward with patient enrollment, the medical community will be watching closely for results that could potentially transform concussion management and establish new standards of care for mild traumatic brain injury patients worldwide.