Oragenics Inc. (NYSE American: OGEN), a clinical-stage biotechnology company, has announced the selection of Southern Star Research as its Clinical Research Organization (CRO) for the Phase IIa trial of ONP-002, a novel intranasal therapy for mild traumatic brain injury (mTBI), commonly known as concussion. This randomized, double-blind, placebo-controlled study aims to assess the safety, tolerability, pharmacokinetics, and early pharmacodynamic effects of ONP-002, a proprietary intranasal neurosteroid designed to optimize brain delivery while minimizing systemic exposure.
The collaboration between Oragenics and Southern Star Research signifies a critical advancement in the development of ONP-002, which seeks to fill a significant gap in concussion treatment options. With approval from the Human Research Ethics Committee in Australia secured, the teams are now focusing on finalizing site selection and preparing for patient enrollment. Janet Huffman, CEO of Oragenics, emphasized the importance of this partnership in moving forward with the trial, underscoring the potential impact of ONP-002 on patients suffering from mTBI.
Concussions represent a growing concern worldwide, with millions of cases reported annually. The lack of effective treatments has spurred interest in innovative approaches like ONP-002, which leverages intranasal delivery to target the brain directly. This method could offer a safer and more effective alternative to traditional treatments, addressing the urgent need for solutions in this area.
For further details on Oragenics and its initiatives, visit https://www.Oragenics.com. Updates related to OGEN can be found in the company’s newsroom at https://ibn.fm/OGEN.
This development not only marks a pivotal moment for Oragenics but also for the broader medical and scientific communities, as it opens new avenues for treating concussions and potentially other neurological conditions. The outcome of the Phase IIa trial could have far-reaching implications, offering hope to those affected by mTBI and setting a precedent for future research in intranasal drug delivery systems.
