Oragenics, Inc. Prepares Intranasal Pharmaceutical, ONP-002, for Phase II Concussion Trial

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Oragenics
Oragenics

SARASOTA, Fla., May 16, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a pioneering pharmaceutical company specializing in intranasal treatments for neurological disorders, today 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.

Clinical Trial Preparations
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.

Leadership Insights
“We are privileged to collaborate with exceptional GMP pre-clinical research teams dedicated to optimizing our drug formulation and intranasal device components,” stated Michael Redmond, President of Oragenics. "Our continued partnership with Avance Clinical has been instrumental in ensuring a seamless transition into our Phase II clinical trial.”

Preclinical studies have demonstrated that ONP-002 significantly improves molecular and behavioral outcomes following brain injury. Additionally, intranasal delivery of ONP-002 as a nanoparticle has shown enhanced brain exposure and metabolism, underlining the potential of this innovative treatment.

Dr. James Kelly, Chief Medical Officer of Oragenics, added, “Our Phase I human study has confirmed that ONP-002 is well tolerated in humans. We are encouraged by the progress and support we have received in optimizing our program, setting the stage for the launch of our Phase II trials.”