Oragenics (NYSE American: OGEN) announced it has received final Human Research Ethics Committee approval in Australia to begin its Phase IIa clinical trial evaluating ONP-002, its lead intranasal neurosteroid drug candidate for the treatment of concussion, also known as mild traumatic brain injury. With all regulatory approvals secured, the company has initiated clinical site onboarding at three locations in Australia, led by Bayside Health (Alfred Health), and expects to dose the first patient before the end of March. The randomized, placebo-controlled study will enroll 40 patients to evaluate safety, tolerability and feasibility of ONP-002, with data expected before year-end 2026 as the company prepares for a future investigational new drug application to support additional U.S. clinical trials.
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