Oragenics Selects Southern Star Research as Clinical Research Organization for ONP-002 Phase IIa Trial

Core Viewpoint - Oragenics, Inc. has selected Southern Star Research as its Clinical Research Organization (CRO) for the upcoming Phase IIa clinical trial of ONP-002, aimed at treating concussion, highlighting the strategic partnership's importance for operational readiness and study initiation [1][2][3]. Group 1: Company Overview - Oragenics, Inc. is a clinical-stage biotechnology company focused on intranasal drug delivery for neurological conditions, with its lead candidate ONP-002 in clinical development for concussion treatment [7]. - Southern Star Research is a full-service CRO with expertise in early-phase trials across Australia and Asia-Pacific, known for its operational rigor and regulatory knowledge [2][8]. Group 2: Clinical Trial Details - The Phase IIa trial will be a randomized, double-blind, placebo-controlled study evaluating ONP-002 in adults with mild traumatic brain injury (mTBI), assessing safety, tolerability, pharmacokinetics (PK), and early pharmacodynamic (PD) effects [5][6]. - The study has received Human Research Ethics Committee (HREC) approval, and patient enrollment and dosing are expected to begin shortly [3][4]. Group 3: Strategic Advantages - Conducting the study in Australia offers several advantages, including streamlined regulatory processes, access to experienced trial sites, and eligibility for Australia's R&D tax incentive program, enhancing cost-efficiency [9]. - ONP-002 is a proprietary intranasal neurosteroid designed to improve drug delivery to the brain while minimizing systemic exposure, showing promise in preclinical models for reducing brain inflammation and improving cognitive functions [4].