Oragenics Inc. (OGEN), a clinical-stage biotechnology company, on Monday announced the dosing of the first patient in the Phase 2a trial for ONP-002, the company's lead candidate for treating concussions and mild traumatic brain injury (mTBI).
Currently, there is no pharmacological treatment for mTBI approved by the U.S. Food and Drug Administration (FDA).
ONP-002 is an investigational, first-in-class, intranasal, novel neurosteroid, designed to reduce neuroinflammation, oxidative stress and edema in the brain. The neuroprotective agent was developed using Oragenics' proprietary intranasal spray dry powder and showed good results in Phase 1 and preclinical studies.
The Phase 2a trial is a randomized, placebo-controlled study that plans to administer ONP-002 to 40 patients within 12 hours of a concussion. The safety and tolerability of the drug will be evaluated through follow-up visits and neurocognitive testing.
The company expects to file an investigational new drug (IND) application by the fourth quarter of 2026, following which the Phase 2b will be initiated.
OGEN closed Monday at $0.68, up 12.95%. In premarket trading, the stock is down 0.06% at $0.68.
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