Oragenics has chosen Australia-based Southern Star Research as the clinical research organisation (CRO) for a randomised Phase IIa trial of its lead concussion drug candidate, ONP-002.
The intranasal neurosteroid, ONP-002, is tailored to optimise drug delivery to the brain while reducing systemic exposure.
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The upcoming double-blind, placebo-controlled trial will assess the tolerability, safety, pharmacokinetics, and early pharmacodynamic effects of the drug in the adult population with mild traumatic brain injury (mTBI).
Both patient enrolment and dosing for the trial are anticipated to commence soon.
With the necessary Human Research Ethics Committee approval in place, the company is now working towards completing site selection, finalising investigator agreements for the trial and trial site initiation preparation.
Oragenics CEO Janet Huffman said: “This marks a pivotal step toward initiating our Phase IIa clinical trial, and we remain committed to rapidly advancing this programme to address the significant unmet need in concussion treatment.
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By GlobalData“With our study infrastructure nearly in place, we are excited to begin patient enrolment and move one step closer to delivering a therapeutic option for those impacted by mild traumatic brain injury.”
Preclinical models have shown that the drug may enhance memory and cognition, aid sensory-motor function recovery, and decrease inflammation in the brain.
Oragenics has decided to carry out the study in Australia due to the streamlined regulatory and ethics approval processes, experienced concussion trial sites, and the financial benefits of the country’s research and development tax incentive programme, improving the trial’s cost-efficiency.
Southern Star Research managing director and founder Dr David Lloyd said: “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 programme here in Australia, paving the way for a larger Phase IIb programme.”
