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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About Oragenics, Inc.
Oragenics, Inc. is a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology. The Company is working on advancing its lead candidate, ONP-002, as a potential first-in-class treatment for concussion and mild traumatic brain injury. Oragenics is working on commencing clinical trials in Australia for ONP-002 , with U.S. Phase 2b trials planned to follow. The Company’s intranasal delivery platform has potential applications across multiple neurological conditions, including Parkinson’s disease, Alzheimer’s disease, PTSD, and anxiety disorders. Oragenics is committed to developing innovative therapies that address significant unmet medical needs in neurological care. For more information, visit oragenics.com.
NOTE TO INVESTORS:The latest news and updates relating to OGEN are available in the company’s newsroom at https://nnw.fm/OGEN
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