Oragenics, Inc. announced on March 6, 2025, the submission of its Investigator’s Brochure (IB) application in preparation for its Phase II clinical trial using ONP-002 in Australia. This marks an important step in advancing ONP-002 as a potential treatment for mild traumatic brain injury (mTBI).
The IB provides investigators with comprehensive clinical and non-clinical data on ONP-002, including its safety, pharmacokinetics, and pharmacodynamics. This document is a critical foundation for the study, guiding investigators on protocol requirements such as dosing and safety monitoring.
Interim CEO Janet Huffman stated that this submission brings the company closer to initiating its clinical trial. Oragenics anticipates receiving final regulatory approvals soon, which should allow for the initiation of the clinical trial in the coming weeks.
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