Oragenics Initiates First Clinical Site for Phase IIa Trial of Intranasal Concussion Treatment

Oragenics Inc. has completed the first site initiation visit for its Phase IIa clinical trial evaluating ONP-002 in Australia, formally launching clinical trial operations at the initial site of three planned locations. The randomized, placebo-controlled study will enroll 40 patients presenting with acute concussion or mild traumatic brain injury, with the first dose administered within 12 hours of injury to evaluate safety, tolerability and preliminary clinical signals. This milestone represents significant progress for a potential treatment addressing a condition affecting an estimated 69 million people globally each year with no approved pharmacological treatment currently available.

The company's lead candidate, ONP-002, is a first-in-class intranasal neurosteroid in Phase IIa clinical development for the treatment of concussion and mild traumatic brain injury. Oragenics' proprietary intranasal delivery platform is designed to enable rapid, non-invasive delivery of therapeutics directly to the brain by bypassing the blood-brain barrier, potentially offering a novel approach to treating neurological conditions. The remaining two trial sites are currently completing Research Governance Office reviews following earlier Human Research Ethics Committee approval and are expected to activate soon, positioning all three sites to begin patient enrollment and dosing in the near term.

The initiation of this clinical trial represents a critical step forward in addressing a significant unmet medical need in neurology and traumatic brain injury treatment. Concussion and mild traumatic brain injury represent a substantial public health concern worldwide, with current management primarily focused on symptom monitoring and rest rather than pharmacological intervention. The development of ONP-002 through Oragenics' specialized delivery technology could potentially transform treatment paradigms for these conditions if clinical trials demonstrate efficacy and safety.

As a clinical-stage biotechnology company pioneering brain-targeted therapeutics, Oragenics is exploring broadening its central nervous system pipeline strategy through both internal development and strategic business development. The successful activation of additional trial sites and subsequent patient enrollment will provide crucial data on whether this innovative approach to drug delivery can effectively treat acute neurological injury. For more information about the company's research and development efforts, visit https://www.Oragenics.com.