Oragenics Advances Concussion Treatment with Phase II Trial Approval in Australia
TL;DR
Oragenics (NYSE American: OGEN) gains HREC approval for Phase II trial of ONP-002, enhancing market position.
ONP-002 Phase II trial for mTBI treatment approved by Australia's HREC, starting patient enrollment in Q2 2025.
Oragenics' ONP-002 therapy offers hope for better treatment of concussion, advancing neuroprotective solutions globally.
Innovative intranasal neuroprotective therapy ONP-002 shows promise in reducing brain inflammation and swelling, potentially revolutionizing mTBI treatment.
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Oragenics Inc., a biotechnology company specializing in intranasal therapies, has secured approval from Australia's Human Research Ethics Committee to initiate a Phase II clinical trial for ONP-002, its innovative neuroprotective treatment for mild traumatic brain injury (mTBI).
The trial represents a significant milestone in addressing concussion treatment, with potential enrollment beginning as early as the second quarter of 2025 at Level 1 trauma emergency departments. ONP-002 is a non-invasive intranasal formulation that has previously demonstrated safety in Phase I trials and promising efficacy in preclinical models.
Preliminary research indicates the therapy's potential to reduce key physiological responses associated with brain trauma, including inflammation, oxidative stress, and brain swelling. This approach could represent a transformative method for managing concussions, which affect millions of individuals annually across sports, military, and civilian environments.
CEO Janet Huffman highlighted the international expansion of the ONP-002 program, with potential enrollment sites being considered in New Zealand alongside the Australian trial. The development signals a strategic approach to addressing brain injury treatment on a global scale.
The trial's potential success could have broad implications for medical treatment of mild traumatic brain injuries, offering a novel therapeutic approach that differs from current management strategies. By targeting inflammation and swelling through an intranasal delivery method, ONP-002 represents an innovative approach to neurological trauma management.
Curated from InvestorBrandNetwork (IBN)
