Oragenics, Inc. (NYSE American: OGEN), a company dedicated to developing innovative intranasal pharmaceuticals for neurological disorders, has revealed its readiness to embark on the final stages of GMP manufacturing and formulation for its drug candidate, ahead of the anticipated Phase IIA clinical trial. This drug candidate, set to be combined with a pioneering intranasal device, aims to address mild Traumatic Brain Injury, commonly known as concussion. Oragenics’ leading drug, ONP-002, represents a new chemical entity (NCE) designed to specifically target the brain via a self-propelled powdered delivery mechanism into the nasal cavity and onward to the brain. A previous Phase I human study involving 40 patients demonstrated the safety and tolerability of ONP-002.
Currently, Oragenics is in the process of manufacturing the Active Pharmaceutical Ingredient (API), which will subsequently undergo formulation and spray drying to produce a nanoparticle powder. This powder will then be loaded into an intranasal device, believed to be novel, that utilizes breath propulsion. Oragenics anticipates that this device will enhance intranasal binding to the olfactory nerve beds, facilitating direct delivery to the brain. This innovative approach is designed for rapid field application, enabling early intervention for concussed patients during the critical initial stages of injury escalation. Phase II trials will target individuals aged 18-55 in the acute phase following concussion.
Animal studies have demonstrated that intranasal delivery of ONP-002 nanoparticles enhances brain exposure and metabolism. Michael Redmond, President of Oragenics, expressed enthusiasm for the impending completion of manufacturing and formulation work for ONP-002, signaling the imminent Phase II study.
Concussion represents a significant unmet medical need, with an estimated 69 million cases reported globally each year. Causes include falls, motor vehicle accidents, and sports-related injuries. Furthermore, concussion has been linked to various neurological disorders such as Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE), with post-concussion syndrome potentially resulting in long-term disability for up to 20% of patients.
Greg Gironda, Oragenics Operational Consultant, highlighted the importance of GMP facility manufacturing and formulation to ensure the integrity of the drug throughout the trials. Looking ahead, the company is eager to commence the Phase II trial and advance the development of its novel drug-device combination for the treatment of mild Traumatic Brain Injury.
Forward-Looking Statements
This communication contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, pertaining to the Company’s ability to successfully undertake Phase II clinical trials using its novel drug-device combination for mild Traumatic Brain Injury treatment. These statements are based on management’s beliefs, assumptions, and available information. Investors are cautioned about the risks and uncertainties that could lead to actual results differing materially from these forward-looking statements. Factors include the company’s ability to advance product development, secure funding, navigate regulatory processes, protect intellectual property, competition in concussion treatments, and general economic conditions. The company does not assume any obligation to publicly revise or update forward-looking statements, except as required by law.
