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

SARASOTA, Fla., March 06, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE:OGEN), a biotechnology company advancing innovative treatments for concussion and brain-related health conditions, today 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.

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.

Mild TBI, commonly known as a concussion, is a form of head trauma that temporarily disrupts brain function. Symptoms often include headache, dizziness, confusion, and cognitive impairment. Despite the high incidence of concussions, no FDA-approved drug therapies currently exist, leaving a significant unmet medical need.

"The submission of our Investigator's Brochure application marks a critical step forward in advancing our clinical program for ONP-002," said Janet Huffman, Interim CEO of Oragenics. "This submission brings us closer to initiating our clinical trial, and we remain committed to delivering a much-needed therapeutic option for patients suffering from mTBI. We anticipate receiving final regulatory approvals that should allow us to initiate our clinical trial in the coming weeks, and are focused on ensuring a smooth trial launch and look forward to sharing updates as we progress."

About the Phase II Study

The randomized, double-blind, placebo-controlled Phase II trial is designed to assess the feasibility, safety, tolerability, blood biomarker response, and pharmacokinetics/pharmacodynamics of ONP-002 in adults with mTBI. The study is designed to enroll 40 participants across two treatment arms—20 receiving ONP-002 and 20 receiving a placebo. It is anticipated that participants will receive a total of nine doses over five days, with the first dose administered within 12 hours of injury. Cognitive testing, visual motor testing, and blood biomarker analysis will be used to evaluate the impact of ONP-002 on brain function and recovery.

Investor Contact

Rich Cockrell

404.736.3838

[email protected]

About Oragenics, Inc.

Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases, including drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), as well as proprietary powder formulation and an intranasal delivery device. For more information, please visit www.oragenics.com.

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