Oragenics (NYSE American:OGEN) announced the submission of an Investigator Brochure (IB) in preparation for its Phase 2 trial evaluating ONP-002 for mild traumatic brain injury (mTBI), commonly known as concussion.
According to the company, the IB serves as a critical foundation for the study, providing investigators with comprehensive clinical and non-clinical data on ONP-002, including its safety, pharmacokinetics, and pharmacodynamics.
In a statement, interim CEO of Oragenics, said, “The submission of our IP application marks a critical step forward in advancing our clinical program for ONP-002. 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.”
