Oragenics (NYSE American: OGEN) a biotechnology company developing intranasal therapies for brain-related disorders, announced it has received approval from Australia’s Human Research Ethics Committee (“HREC”) to begin a Phase II clinical trial of ONP-002, its proprietary neuroprotective therapy for mild traumatic brain injury (mTBI), or concussion. The clearance enables the company to initiate patient enrollment as early as Q2 2025 at Level 1 trauma emergency departments, where concussed patients are often treated. ONP-002, a non-invasive intranasal formulation, has demonstrated safety in Phase I and efficacy in preclinical models by reducing inflammation, oxidative stress and brain swelling. CEO Janet Huffman said the approval marks a key step toward expanding the ONP-002 program internationally, with enrollment sites also under consideration in New Zealand.
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About Oragenics
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, visit the company’s website at www.Oragenics.com
NOTE TO INVESTORS: The latest news and updates relating to OGEN are available in the company’s newsroom at https://ibn.fm/OGEN
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