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

Core Viewpoint - Oragenics, Inc. has submitted its Investigator's Brochure for ONP-002, a novel intranasal neurosteroid, in preparation for a Phase II clinical trial aimed at treating mild traumatic brain injury (mTBI) [1][5] Group 1: Clinical Development - The submission of the Investigator's Brochure is a significant milestone in advancing the clinical program for ONP-002, bringing the company closer to initiating the clinical trial [5] - The Phase II trial will assess the feasibility, safety, tolerability, and pharmacokinetics of ONP-002 in adults with mTBI, enrolling 40 participants in a randomized, double-blind, placebo-controlled design [6] - Participants will receive a total of nine doses over five days, with the first dose administered within 12 hours of injury, and various cognitive and biomarker tests will be conducted to evaluate the drug's impact [6] Group 2: Product Background - ONP-002 has shown promising preclinical results, indicating its potential to reduce inflammation, oxidative stress, and brain swelling [2] - A prior Phase I study confirmed the safety and tolerability of ONP-002 at multiple intranasal doses in healthy adults [2] - The Investigator's Brochure includes comprehensive clinical and non-clinical data on ONP-002, serving as a critical foundation for the study [3] Group 3: Market Context - Mild TBI, or concussion, is a common form of head trauma with no FDA-approved drug therapies currently available, highlighting a significant unmet medical need [4] - The company is focused on delivering a therapeutic option for patients suffering from mTBI, with expectations of receiving regulatory approvals to initiate the trial soon [5]