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

July 31st, 2025 1:35 PM
By: Newsworthy Staff

Oragenics Inc. has partnered with Southern Star Research to advance the Phase IIa trial of ONP-002, a promising intranasal therapy for mild traumatic brain injury, addressing a critical unmet need in concussion treatment.

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 the selection of Southern Star Research as its Clinical Research Organization (CRO) for the upcoming Phase IIa trial of ONP-002, an intranasal therapy targeting 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 is a significant milestone in the development of ONP-002, as it moves closer to addressing the urgent need for effective concussion treatments. 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 advancing the therapeutic potential of ONP-002 for individuals suffering from mTBI.

For more details on this development, visit https://ibn.fm/wnBYr. Further information about Oragenics and its innovative approaches to treating neurological conditions and infectious diseases can be found at http://www.Oragenics.com. Updates related to OGEN are available in the company’s newsroom at https://ibn.fm/OGEN.

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