Oragenics, Inc. Announces Health and Disability Ethics Committee Submission for Phase IIa Concussion Trial

Core Viewpoint - Oragenics, Inc. has submitted a clinical trial protocol for its neurosteroid therapy ONP-002 to the Health and Disability Ethics Committee in New Zealand, marking a significant step in the development of treatments for mild traumatic brain injury (mTBI) or concussion [1][2][3] Company Overview - Oragenics, Inc. is a biotechnology company focused on developing intranasal therapeutics for neurological disorders, with ONP-002 as its lead candidate for treating mTBI or concussion [4] - The company is also advancing proprietary powder formulations and intranasal delivery technology to enhance drug administration [4] Clinical Trial Details - The Phase II clinical trial for ONP-002 aims to evaluate its efficacy in treating mTBI or concussion, with patient enrollment planned in both Australia and New Zealand [2][3] - The trial will be conducted at Christchurch Hospital, the largest tertiary, teaching, and research hospital on New Zealand's South Island, which treats over 83,000 patients annually [2][3] Treatment Significance - There are currently no pharmaceutical therapies available for treating concussion, highlighting an unmet medical need [3] - ONP-002 is designed for intranasal administration, providing a non-invasive and efficient route for drug delivery to the brain, and has shown promising results in preclinical models [3]