Oragenics Inc. Selects Southern Star Research for Phase IIa Trial of Intranasal Concussion Therapy ONP-002

Oragenics Inc. (NYSE American: OGEN), a clinical-stage biotechnology company, has announced its selection of Southern Star Research as the Clinical Research Organization (CRO) for the upcoming Phase IIa trial of ONP-002, its innovative intranasal therapy for mild traumatic brain injury (mTBI), commonly known as concussion. This trial represents a significant step forward in the development of treatments for mTBI, a condition with limited therapeutic options currently available.

The Phase IIa trial will be a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics, and early pharmacodynamic effects of ONP-002. This proprietary intranasal neurosteroid is designed to enhance brain delivery while minimizing systemic exposure, potentially offering a safer and more effective treatment option for concussion patients. With approval from the Human Research Ethics Committee in Australia secured, Oragenics and Southern Star are now focusing on finalizing site selection and preparing for patient enrollment.

Janet Huffman, CEO of Oragenics, emphasized the importance of this partnership, stating it marks a pivotal moment in the company's efforts to address the significant unmet need in concussion treatment. The collaboration with Southern Star Research underscores Oragenics' commitment to advancing innovative therapies for neurological conditions through its specialized intranasal drug delivery platform.

For more information on Oragenics and its pipeline of intranasal therapies, visit https://www.Oragenics.com. Updates on OGEN can also be found in the company's newsroom at https://ibn.fm/OGEN.

This development is particularly noteworthy given the growing awareness of the long-term effects of concussions and the urgent need for effective treatments. The success of ONP-002 could revolutionize the approach to mTBI management, offering hope to millions affected by this condition worldwide.