(RTTNews) - Oragenics, Inc. (OGEN) has officially launched clinical operations for its Phase IIa trial of ONP-002, completing the first site-initiation visit in Australia- a key step that moves the program from regulatory preparation into active trial execution.
The first of three planned Australian sites is now trained, staffed, and ready to enroll patients. The remaining two sites are undergoing final Research Governance Office (RGO) reviews, the last administrative requirement following Human Research Ethics Committee (HREC) approval. Oragenics expects both sites to activate in the near term, enabling full enrollment to begin shortly.
The Phase IIa study is a randomized, placebo-controlled study evaluating the safety, tolerability, and preliminary clinical signals of ONP-002 in patients with acute concussion and mild traumatic brain injury. The trial aims to enroll 40 patients, with dosing required within 12 hours of injury. Primary endpoints include safety assessments, neurocognitive follow-up, and patient compliance.
ONP-002 is a first-in-class intranasal neurosteroid designed to directly target the neuroinflammatory cascade triggered by brain trauma. Earlier Phase 1 data showed the therapy was safe and well tolerated, and there are currently no FDA-approved pharmacological treatments for concussion.
CEO Janet Huffman said the company is "ready for patient dosing," noting that site activation represents disciplined execution toward bringing a much-needed therapy to a large, underserved patient population.
OGEN has traded between $0.61 and $9.60 over the past year. The stock is trading at $0.98, up 11.36%.
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