EXCLUSIVE: Oragenics Completes Key FDA-Recognized Study For Concussion Drug Candidate

On Tuesday, Oragenics Inc. OGEN said it has completed a key study for its new concussion drug, ONP-002.

What Happened: A recent study shows that the drug successfully targets areas inside the nose connected to the brain, making the drug more likely to reach and treat the brain after a concussion.

In the study, ONP-002 was tested using a nasal spray device. The goal of intranasal casting studies is to identify where the drug lands inside a cast metal anatomical model of the interior nose.

The model is standard for intranasal drug delivery and is accepted by the FDA as a surrogate for the actual nasal passage.

The results showed that the drug spreads well in the nose areas, where it can be quickly absorbed into the brain.

Also Read: EXCLUSIVE: Oragenics Completes Spray Dry Drug Manufacturing, Intranasal Device Filling For Anticipated Mid-Stage Study For Patients With Brain Injury.

Why It Matters: Oragenics is now preparing to move forward with human testing (Phase 2) in patients who come to the emergency room with a concussion, aiming to give the first dose of the drug within 8 hours of the injury.

“In preparing for our Phase 2 study, we wanted to study whether our nasal spray device would give ONP-002 an increased chance of reaching the brain quickly after a concussion. The study results are promising, as they show the drug targets areas in the nose directly linked to the brain. This should increase the chances of the drug being effective in treating concussion and reduces the likelihood of it being swallowed, which is another encouraging sign,” said Michael Redmond, President of Oragenics.

In August, Oragenics completed a study that indicates ONP-002 does not cause cardiotoxicity.

A concussion is a mild traumatic brain injury that affects brain function, with an estimated 69 million cases reported annually worldwide.

Long-term symptoms can develop in up to 20% of patients. Currently, there is no pharmaceutical treatment for concussions.

Price Action: OGEN stock closed at $0.39 on Monday.

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