Oragenics, Inc. announced an update on the company and its drug development program. Oragenics is designing an upcoming Phase II clinical trial conducted in acute and emergency departments. The company is preparing to initiate a Phase II clinical trial for its lead drug candidate, ONP-002, an innovative neurosteroid designed to treat mild Traumatic Brain Injury (mTBI), commonly referred to as concussion.

Advancements in Drug Formulation for Phase II Trial: Oragenics is focused on enhancing the formulation of ONP-002 by increasing the percentage of active compound in the final spray-dried intranasal powder. The formulation improvements aim to optimize the size of the emitted particles, ensuring they are large enough to prevent deep lung inhalation while maximizing intranasal absorption and brain targeting. This intranasal delivery method is crucial for bypassing the blood-brain barrier, facilitating rapid and efficient drug delivery to the brain within minutes.

In preparation for the Phase II clinical trial, Oragenics has secured an adequate supply of intranasal devices. The company has also partnered with Avance Clinical Pty Ltd, a renowned Clinical Research Organization (CRO) based in Adelaide, Australia. This collaboration will facilitate the implementation of the Phase IIa trial in emergency departments at level one trauma centers, which Oragenics anticipates will result in a robust and well-structured study.