Core Insights - Oragenics, Inc. has entered into a manufacturing agreement with Sterling Pharma Solutions for the GMP production of its lead drug candidate, ONP-002, aimed at treating concussion [1][2][3] - This partnership is a significant milestone for Oragenics, ensuring domestic production capabilities ahead of planned Phase IIb clinical trials expected to start next year [2][4] - The collaboration emphasizes Oragenics' commitment to quality and efficiency in developing treatments for neurological trauma, starting with concussion, which currently lacks FDA-approved pharmacological therapies [4][5] Company Overview - Oragenics, Inc. is a biotechnology company focused on developing intranasal therapeutics for neurological disorders, with ONP-002 targeting mild traumatic brain injury (mTBI) [5] - The company's intranasal delivery technology aims to provide fast, targeted, and non-invasive therapy to the brain [5] Partner Overview - Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with over 50 years of experience in small molecule API development and manufacturing [6][7] - The company specializes in handling complex API challenges and has multiple facilities in the US and UK, employing over 1,350 people [7]

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]