Oragenics Inc. Selects Southern Star Research for Phase IIa Trial of Innovative Concussion Therapy

Oragenics Inc. (NYSE American: OGEN), a clinical-stage biotechnology company, has taken a significant step forward in the development of its innovative intranasal therapy for mild traumatic brain injury (mTBI), commonly known as concussion, by selecting Southern Star Research as the Clinical Research Organization (CRO) for the Phase IIa trial of ONP-002. This collaboration is pivotal in advancing a treatment that could revolutionize the management of concussions, a condition currently with limited therapeutic options.

The Phase IIa trial is designed as a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics, and early pharmacodynamic effects of ONP-002. This proprietary neurosteroid is specifically engineered to enhance delivery to the brain while minimizing systemic exposure, offering a promising new approach for treating neurological conditions. With the Human Research Ethics Committee in Australia's approval secured, the focus now shifts to finalizing site selection and preparing for patient enrollment, marking a critical milestone in the drug's development pathway.

Janet Huffman, CEO of Oragenics, highlighted the significance of this partnership, noting it as a crucial step towards addressing the substantial unmet need in concussion treatment. The collaboration between Oragenics and Southern Star Research not only underscores the potential of ONP-002 to provide a novel therapeutic option for mTBI patients but also reflects the growing recognition of the need for innovative treatments in this area. Mild traumatic brain injury affects millions globally, yet effective treatments remain elusive, making the development of ONP-002 a potentially transformative advancement in neurology.

For further details on Oragenics and its pioneering work in neurological conditions and infectious diseases, visit https://www.Oragenics.com. Additional updates and news regarding OGEN are available in the company's newsroom at https://ibn.fm/OGEN.