Oragenics, Inc. Submits Investigator’s Brochure for Phase II Clinical Trial of ONP-002 in Mild Traumatic Brain Injury

UF Innovate | Accelerate graduate Oragenics, Inc. announced the submission of its Investigator’s Brochure (IB) application in preparation for its Phase II clinical trial using ONP-002 in Australia. This milestone represents an important step in advancing ONP-002, a novel intranasal neurosteroid, as a potential treatment for mild traumatic brain injury (mTBI), commonly known as concussion.

ONP-002 has demonstrated promising preclinical results, showing the potential to reduce inflammation, oxidative stress, and brain swelling. A prior Phase I study in healthy adults confirmed the drug’s safety and tolerability at multiple intranasal doses. This upcoming Phase II study aims to establish the feasibility of acute intranasal administration in mTBI patients and generate initial proof-of-concept data through cognitive testing, visual motor testing, and biomarker analysis.

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