Oragenics Selects Southern Star Research As Clinical Research Organization For Upcoming Phase IIa Clinical Trial Of ONP-002, Lead Drug Candidate For Concussion

Oragenics, Inc. (NYSE:OGEN), a clinical-stage biotechnology company pioneering intranasal drug delivery for neurological conditions, today announced the selection of Southern Star Research as its Clinical Research Organization (CRO) for the upcoming Phase IIa clinical trial of ONP-002, the company's lead drug candidate for concussion.

Southern Star Research is a globally recognized, full-service CRO with a proven track record in delivering early-phase trials across Australia and Asia-Pacific. Their deep operational expertise, regulatory knowledge, and hands-on site management capabilities will support the execution of Oragenics' randomized, double-blind, placebo-controlled Phase IIa study evaluating ONP-002 in adults with mild traumatic brain injury (mTBI).

ONP-002 is a proprietary intranasal neurosteroid with a novel delivery mechanism designed to enhance drug delivery to the brain while minimizing systemic exposure. In preclinical models, ONP-002 demonstrated reduced brain inflammation, improved memory and cognition, and recovery of sensory-motor function.

The Phase IIa trial will evaluate the safety, tolerability, pharmacokinetics (PK), and early pharmacodynamic (PD) effects of ONP-002 in adults with mTBI.