Oragenics, Inc. announced on April 9, 2025, that it submitted a clinical trial protocol for regulatory review to the Health and Disability Ethics Committee (HDEC) in New Zealand. This submission is a critical milestone for advancing the company’s Phase II clinical trial evaluating ONP-002.
ONP-002 is Oragenics' proprietary neurosteroid therapy for mild traumatic brain injury (mTBI). The submission to the HDEC in New Zealand expands the potential geographic footprint for patient enrollment in the upcoming Phase IIa trial.
This move aims to accelerate the clinical development timeline for ONP-002. Expanding trial sites beyond Australia to include New Zealand could facilitate faster patient recruitment and data collection.
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