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

On Tuesday, Oragenics Inc. (NYSE: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 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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