Oragenics, Inc. Opens Second Clinical Site for Phase IIa Trial of ONP-002, Evaluating Treatment for Concussion with 60 Participants

Oragenics, Inc. has initiated operations at a second clinical site for its Phase IIa clinical trial of ONP-002, which is being investigated as a treatment for concussion and mild traumatic brain injury (mTBI). The company is evaluating the safety and efficacy of ONP-002 in patients diagnosed with concussion or mild traumatic brain injury.

The Phase IIa trial is a randomized, double-blind, placebo-controlled study. It is designed to assess the drug’s impact on neuroinflammation and cognitive function following a concussion. The trial plans to enroll approximately 60 participants who have experienced a recent mTBI. Participants will be randomly assigned to receive either ONP-002 or a placebo. Researchers will then evaluate changes in cognitive and neurological function over a period of several weeks. The primary outcome measures include assessments of cognitive performance, symptom severity, and biomarkers of brain injury.

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Date: May 5, 2026

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