Oragenics Inc. (NYSE American: OGEN) announced that two patients have been enrolled and eight doses administered in its ongoing Phase IIa clinical trial evaluating ONP-002, its lead candidate for the treatment of mild traumatic brain injury (mTBI), or concussion. The trial is underway at Mackay Base Hospital in Queensland, Australia, with additional sites nearing activation, as the company advances a first-in-class intranasal neurosteroid designed to target the underlying biological effects of brain injury.
This development addresses a significant unmet need in a market with no FDA-approved pharmacological treatments for concussion. 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.
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