Oragenics Inc. Advances ONP-002 Phase IIa Trial with Southern Star Research as CRO

Oragenics Inc. (NYSE American: OGEN), a clinical-stage biotechnology company specializing in intranasal drug delivery for neurological conditions, has announced the selection of Southern Star Research as its Clinical Research Organization (CRO) for the upcoming Phase IIa trial of ONP-002. This innovative therapy targets mild traumatic brain injury (mTBI), commonly known as concussion, through a proprietary intranasal neurosteroid designed to optimize brain delivery while minimizing systemic exposure.

The trial, which has already received Human Research Ethics Committee approval in Australia, is set to be a randomized, double-blind, placebo-controlled study. It aims to assess the safety, tolerability, pharmacokinetics, and early pharmacodynamic effects of ONP-002. With site selection in its final stages, Oragenics and Southern Star Research are gearing up for patient enrollment, a critical milestone in the development of this potential breakthrough treatment.

Janet Huffman, CEO of Oragenics, emphasized the significance of this partnership, stating it represents a pivotal advancement in the company's mission to tackle the considerable unmet need in concussion treatment. The collaboration underscores Oragenics' commitment to leveraging innovative intranasal delivery technologies to address complex neurological conditions.

For further details on Oragenics and its pioneering work in intranasal drug delivery, visit https://www.Oragenics.com. Updates and news related to OGEN can be found in the company's newsroom at https://ibn.fm/OGEN.