EXCLUSIVE: Oragenics' Concussion Drug Clears FDA-Required Cardiotoxicity Testing, Planning For Phase II Trials Underway

On Thursday, Oragenics Inc. OGEN announced that its lead candidate for treating concussion completed a study that indicates ONP-002 does not cause cardiotoxicity.

ONP-002 is a new chemical entity (NCE) designed to target the brain by being delivered into the nasal cavity and then onward to the brain.

Before conducting a clinical trial, the FDA requires pharmaceuticals to be tested on cardiac receptors to ensure that they do not show any causes of electrical malformations.

Oragenics conducted hERG ion channel studies on ONP-002 under Good Laboratory Practices (GLP) with Charles River Laboratories CRL.

Like previous non-GLP hERG studies, inhibitory concentrations were greater than 10 micromolar.

Based on Phase 1 ONP-002 clinical trial dosing and subsequent blood plasma concentrations, ONP-002 is expected to have a large cardiac safety margin, suggesting that ONP-002 treatment for concussion will not cause cardiac arrhythmia (irregular heartbeat).

Concussion, a mild traumatic brain injury that affects brain function, is a significant unmet medical need, with an estimated 69 million cases reported annually worldwide.

Common causes of concussions include falls, motor vehicle accidents, and contact sports.

According to the CDC, the total annual healthcare cost for nonfatal traumatic brain injuries (TBIs) exceeds $40.6 billion.

Additionally, post-concussion symptoms, which can occur in up to 20% of affected individuals, are linked to long-term disability.

In July, the company said that a Phase 2 study in concussed patients is being planned to assess safety and feasibility while analyzing ONP-002’s effectiveness based on patient blood biomarker profiles and functional outcomes.

In June, Oragenics completed a prototype of its automated intranasal device for use in concussed patients who are initially confused, dazed, or unconscious in the acute phase of injury.

Price Action: OGEN stock was trading higher by 4.50% at $1.01 premarket at the last check on Thursday.

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