Oragenics' Concussion Drug ONP-002 Stable Across Wide Temperature Range

SARASOTA, Fla. — Oragenics, a company dedicated to developing innovative intranasal pharmaceuticals for neurological disorders, has announced promising developments for its lead concussion treatment candidate, ONP-002. This new chemical entity (NCE) aims to treat concussions by delivering medication directly to the brain via a breath-propelled system into the nasal cavity. Remarkably, ONP-002 has demonstrated stability across a wide temperature range, effectively eliminating the need for cold storage, which is often inconvenient.

Oragenics has recently completed the synthesis of the ONP-002 drug batch in preparation for a Phase II clinical trial. The company has reported that the drug maintains over 99% purity for three months at temperatures ranging from -20°C to 104°C. This suggests that ONP-002 does not require cumbersome cold chain protocols during transport and storage, an advantage that could ensure its efficacy in diverse conditions.

Both contact sports and military operations expose individuals to varying temperatures, which may affect drug stability and effectiveness. ONP-002 has been formulated as a spray-dried powder, enhancing its stability in extreme temperatures. Traditional methods that require strict temperature controls can be cumbersome and pose compliance risks during shipping and on-field operations.

Dr. Frank Peacock, Chief Clinical Officer of Oragenics and an emergency medicine physician, expressed his excitement about the drug's potential. “We understand the importance of quickly delivering ONP-002 to the brain following a concussive injury to mitigate the cascade of inflammation and oxidative stress. Given that there is currently no pharmaceutical treatment for concussion, we are optimistic that our intranasal approach will improve treatment efficacy during the acute phase in the field.”

Concussion remains a significant unmet medical need, with an estimated 69 million cases reported globally every year. Common causes include falls, motor vehicle accidents, and contact sports. Furthermore, concussions have been linked to other neurological disorders such as Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE). Post-concussion symptoms can lead to long-term disability and affect up to 20% of patients.

Oragenics is a biotechnology company in its development stage, focusing on nasal delivery of pharmaceutical medications for neurological conditions and infectious diseases. The company's pipeline includes drug candidates for treating mild traumatic brain injury, commonly known as concussion, and Niemann-Pick Disease Type C. Oragenics also specializes in proprietary powder formulations and intranasal delivery devices.

In summary, Oragenics’ innovative ONP-002 represents a promising advance in the treatment of concussions. Its stability across a wide range of temperatures makes it a practical solution for use in various field conditions, potentially overcoming the limitations of existing storage protocols and enhancing compliance during transport and use. With no current FDA-approved treatment for concussions, ONP-002 could pave the way for more effective management of this prevalent and challenging condition.

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