Oragenics Initiates Phase IIa Trial Of ONP-002 For Concussion With Southern Star In Australia

Oragenics, Inc., a clinical-stage biotech company advancing intranasal therapies for neurological conditions, has selected Southern Star Research as its Clinical Research Organization (CRO) for the Phase IIa clinical trial of ONP-002, its lead drug candidate for concussion treatment. The upcoming randomized, double-blind, placebo-controlled study will assess 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. They bring operational rigor, startup speed, and therapeutic area experience needed to move this important program forward efficiently and cost-effectively,” said Dr James Kelly, Chief Medical Officer of Oragenics.

Southern Star Research is a leading full-service CRO with extensive experience conducting early-phase trials in Australia and the broader Asia-Pacific region. With regulatory and ethics approvals already secured, Oragenics is working with Southern Star to finalize trial site selection, investigator agreements, and trial initiation. Patient enrollment is expected to begin shortly. 

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.”

The company’s decision to conduct the study in Australia leverages benefits including streamlined regulatory processes, experienced mTBI trial sites, and cost efficiency via Australia’s R&D tax incentive. ONP-002 is a novel intranasal neurosteroid designed to target brain injury with reduced systemic exposure and has shown promising results in preclinical models.

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.”