Oragenics Prepares ONP-002 for Phase II Concussion Trial

Oragenics, Inc., a trailblazing pharmaceutical company headquartered in Sarasota, Florida, recently shared updates on its drug development initiatives, especially concerning its intranasal treatments for neurological disorders. The company is poised to launch a Phase II clinical trial for its leading drug candidate, ONP-002, which aims to address mild Traumatic Brain Injury (mTBI), commonly known as concussion.

The company is making significant strides in advancing the formulation of ONP-002. By enhancing the concentration of the active compound in the final spray-dried intranasal powder, Oragenics seeks to optimize particle size for effective intranasal absorption while preventing deep lung inhalation. This delivery method is critical for circumventing the blood-brain barrier, allowing rapid and efficient drug delivery to the brain.

As part of the clinical trial preparations, Oragenics has ensured an adequate supply of intranasal devices. Additionally, they have joined forces with Avance Clinical Pty Ltd, a distinguished Clinical Research Organization based in Adelaide, Australia. This partnership is expected to facilitate the execution of the Phase IIa trial in emergency departments at level one trauma centers, promising a comprehensive and well-organized study.

Michael Redmond, President of Oragenics, emphasized the importance of collaboration with top-tier GMP pre-clinical research teams focused on refining the drug formulation and intranasal device components. He acknowledged the invaluable role of Avance Clinical in guiding the company seamlessly into the Phase II clinical trial stage.

Preclinical studies have shown that ONP-002 notably improves molecular and behavioral outcomes post-brain injury. The intranasal delivery of ONP-002 as a nanoparticle has further exhibited increased brain exposure and metabolism, highlighting its potential as a pioneering treatment.

Dr. James Kelly, Chief Medical Officer of Oragenics, reported positive results from the Phase I human study, which confirmed the drug’s tolerability in humans. He expressed optimism about the progress and support received in optimizing the program, setting the stage for the forthcoming Phase II trials.

Concussion remains a significant unmet medical need, with approximately 69 million cases reported globally each year, often resulting from falls, motor vehicle accidents, and contact sports. Concussions are linked with long-term neurological disorders, including Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE). Post-concussion syndrome, leading to long-term disability, impacts up to 20% of concussion patients.

Oragenics is committed to developing innovative intranasal pharmaceutical solutions to address these neurological disorders. Their goal is to provide effective treatments and enhance patient outcomes globally.

Oragenics, Inc. is a biotechnology company in the development stage, focusing on intranasal delivery of pharmaceutical medications for neurological conditions and combating infectious diseases. Their portfolio includes drug candidates for treating mild traumatic brain injury (mTBI) and Niemann Pick Disease Type C (NPC), along with a proprietary powder formulation and an intranasal delivery device.