Oragenics 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).
“Partnering with Southern Star Research ensures we are leveraging experienced, regionally specialized clinical leadership to advance ONP-002,” said Dr James Kelly, Chief Medical Officer of Oragenics. “They bring operational rigor, startup speed, and therapeutic area experience needed to move this important program forward efficiently and cost-effectively.”
Southern Star Research Founder & Managing Director, Dr. David Lloyd commented, “We are pleased to be partnering with Oragenics on the development of ONP-002. The Phase IIa study of self-administered Intranasal ONP-002 in subjects with mild Traumatic Brain Injury is a significant milestone for Oragenics and we are excited to manage the ONP-002 program here in Australia, paving the way for a larger Phase IIb program.”
With Human Research Ethics Committee (HREC) approval already secured, Oragenics is working closely with Southern Star to complete site selection, finalize investigator agreements, and prepare for trial site initiation. Patient enrollment and dosing are expected to begin shortly.
The company’s strategic decision to conduct the study in Australia reflects several advantages:
Access to streamlined regulatory and ethics approval processes
Availability of experienced concussion trial sites
Eligibility for Australia’s R&D tax incentive program, enhancing cost-efficiency
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.
Janet Huffman, Chief Executive Officer of Oragenics, further commented: “This marks a pivotal step toward initiating our Phase IIa clinical trial, and we remain committed to rapidly advancing this program to address the significant unmet need in concussion treatment. With our study infrastructure nearly in place, we are excited to begin patient enrollment and move one step closer to delivering a therapeutic option for those impacted by mild traumatic brain injury.”