Oragenics Inc. Advances ONP-002 Phase IIa Trial with Southern Star Research for Concussion Treatment

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 designed for mild traumatic brain injury (mTBI), commonly known as concussion. This trial represents a critical phase in the development of a treatment that could significantly impact the management of concussions, a condition with limited therapeutic options currently available.

The study, which is randomized, double-blind, and placebo-controlled, aims to assess the safety, tolerability, pharmacokinetics, and early pharmacodynamic effects of ONP-002. This proprietary intranasal neurosteroid is engineered to enhance brain delivery while minimizing systemic exposure, offering a promising approach to concussion treatment. With approval from the Human Research Ethics Committee in Australia secured, Oragenics and Southern Star Research 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 step in advancing ONP-002 towards addressing the significant unmet need in concussion treatment. The collaboration underscores the potential of ONP-002 to revolutionize the therapeutic landscape for mTBI, providing hope for millions affected by concussions annually.

For further details on Oragenics and its groundbreaking work in intranasal drug delivery for neurological conditions, visit https://www.Oragenics.com. Additionally, the latest news and updates regarding OGEN can be found in the company’s newsroom at https://ibn.fm/OGEN.