Oragenics (NYSE American: OGEN), a clinical-stage biotechnology company developing brain-targeted therapeutics using proprietary intranasal delivery technology, announced it has completed the first site initiation visit for its Phase IIa clinical trial evaluating ONP-002 in Australia. The milestone formally launches clinical trial operations at the first of three planned sites, with staff training, protocol orientation and regulatory documentation completed. The randomized, placebo-controlled study will enroll 40 patients presenting with acute concussion or mild traumatic brain injury, with the first dose administered within 12 hours of injury to evaluate safety, tolerability and preliminary clinical signals. The remaining two trial sites are currently completing Research Governance Office reviews following earlier Human Research Ethics Committee approval and are expected to activate soon, positioning all three sites to begin patient enrollment and dosing in the near term.
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ABOUT ORAGENICS
Oragenics, Inc. (NYSE American: OGEN) is a clinical-stage biotechnology company pioneering brain-targeted therapeutics through proprietary intranasal drug delivery technology. The Company’s lead candidate, ONP-002, is a first-in-class intranasal neurosteroid in Phase IIa clinical development for the treatment of concussion and mild traumatic brain injury (mTBI) — conditions affecting an estimated 69 million people globally each year with no approved pharmacological treatment. Oragenics’ intranasal delivery platform is designed to enable rapid, non-invasive delivery of therapeutics directly to the brain by bypassing the blood-brain barrier. The Company is exploring broadening its CNS pipeline strategy through both internal development and strategic business development. For more information, visit 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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