Oragenics submits IB for Phase II clinical trial of ONP-002 in mTBI

Oragenics (OGEN) announced the submission of its Investigator’s Brochure 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, 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. The IB provides investigators with comprehensive clinical and non-clinical data on ONP-002, including its safety, pharmacokinetics, and pharmacodynamics. This document serves as a critical foundation for the study, guiding investigators on protocol requirements such as dosing, intranasal administration protocols, blood biomarker analysis, and safety monitoring. Additionally, the submission enables updates to ClinicalTrials.gov, providing a transparent record of the trial’s details and progress as regulatory approvals advance.