Oragenics Completes Key FDA Study for ONP-002

Oragenics Inc. (NYSE American: OGEN), a biotechnology company based in Sarasota, Florida, has successfully completed an important study for their new drug, ONP-002, aimed at treating concussions. The drug is administered through the nasal passage, potentially allowing it to reach the brain more quickly following a head injury.

The recent study demonstrated that ONP-002 successfully targets specific regions inside the nose that are connected to the brain. This increases the likelihood of the drug being effective in treating concussions by reaching the brain swiftly post-injury. The FDA values such intranasal casting studies for drugs delivered via the nasal route and accepts these studies in submissions. Following these promising results, Oragenics is preparing to advance to Phase II human trials, focusing on patients who visit emergency rooms with concussions, with the goal of administering the first dose within eight hours of injury.

Michael Redmond, President of Oragenics, emphasized the importance of the study in preparation for the Phase II trials. He noted that the nasal spray device used in the study showed promising results, indicating that ONP-002 could quickly reach the brain through the nose. This would enhance the likelihood of the drug being effective in treating concussions and reduce the chances of it being swallowed, which is a positive outcome.

In the study, ONP-002 was tested using a specialized nasal spray device. The purpose of intranasal casting studies is to determine the distribution of the drug within an anatomical model of the inner nose made from cast metal. This model is a standard for intranasal drug delivery and is recognized by the FDA as a substitute for the actual nasal passage. The results showed that the drug spreads efficiently in the nose's regions where it can be rapidly absorbed into the brain, making it a strong candidate for aiding concussion recovery.

Concussions are a prevalent issue, affecting approximately 69 million people annually. They commonly occur due to falls, car accidents, or sports injuries, and up to 20% of patients may develop long-term symptoms. Currently, there are no pharmaceutical treatments available for concussions, which highlights the significance of Oragenics' work in this field.

Oragenics is a development-stage biotechnology company focused on creating nasal delivery systems for pharmaceutical treatments in neurology and combating infectious diseases. Their pipeline includes drug candidates for mild traumatic brain injury (mTBI), also known as concussion, and Niemann Pick Disease Type C (NPC), as well as a proprietary powder formulation and an intranasal delivery device.

The FDA places high importance on studies regarding nasal drug delivery systems and accepts them for pharmaceutical submissions that utilize the nasal route. These studies are essential for evaluating the bioavailability and bioequivalence of drugs, particularly nasal aerosols and sprays. The FDA's guidance on these studies emphasizes using in vitro and in silico methods, including computational simulations, to assess drug deposition and distribution within the nasal cavity. These methods are crucial for ensuring that both new drug applications (NDAs) and abbreviated new drug applications (ANDAs) comply with regulatory requirements.

In conclusion, Oragenics' ONP-002 has shown promising potential in treating concussions through nasal delivery, with studies indicating effective targeting and absorption in the brain. The company is moving forward with human trials, aiming to address a significant unmet need in concussion treatment.