Dr. James Kelly Named CMO for Oragenics' Concussion Phase II Trials

Oragenics, Inc., a company dedicated to developing innovative intranasal pharmaceuticals for neurological disorders, has announced the appointment of Dr. James Kelly as its Chief Medical Officer. Dr. Kelly will be responsible for overseeing the company's upcoming Phase II clinical trial. The trial will focus on ONP-002, Oragenics' lead drug candidate, which is combined with an intranasal device for the treatment of mild Traumatic Brain Injury (TBI), commonly referred to as concussion.

ONP-002 is a novel chemical entity designed to target the brain through delivery into the nasal cavity. A Phase I study involving 40 patients has been completed, demonstrating that the drug is safe and well-tolerated. Dr. Kelly brings a wealth of experience to Oragenics, having previously served as the Executive Director of the Marcus Institute for Brain Health (MIBH) and as a Professor of Neurology at the University of Colorado Anschutz Medical Campus. The MIBH specializes in treating US military veterans with persistent TBI symptoms, funded by the Marcus Foundation.

Dr. Kelly has expressed excitement about joining Oragenics at a crucial time in the drug development process. He has been involved with the drug for several years and is eager to demonstrate its potential to improve patient outcomes in the Phase II trials.

Before his recent roles, Dr. Kelly was the founding Director of the National Intrepid Center of Excellence (NICoE) at Walter Reed National Military Medical Center. There, he led the creation of an interdisciplinary team that integrated high-tech diagnosis and treatment with complementary and alternative medical interventions to care for US military personnel with TBI and psychological conditions.

Michael Redmond, President of Oragenics, has welcomed Dr. Kelly to the team, recognizing him as a leading expert in concussion and other brain injuries. The company is currently finalizing drug manufacturing and formulation at GMP facilities to ensure drug integrity before and during the trials.

Preclinical animal models have shown that the drug can acutely improve molecular and behavioral outcomes following brain injury. Intranasal delivery of the drug as a nanoparticle has also been shown to enhance brain exposure and metabolism in animals. The Phase II study aims to establish the relationship between drug application and blood biomarkers, as well as evaluate clinical endpoints to determine improvements in patient outcomes.

Concussion is a significant medical need, with an estimated 69 million cases reported worldwide annually. Common causes include falls, motor vehicle accidents, and contact sports. Concussion has also been linked to other neurological disorders such as Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE). Post-concussion syndrome can lead to long-term disability and occurs in up to 20% of concussed patients.

The company is committed to advancing the development of its product candidates and is focused on completing the necessary preparations for the Phase II clinical trial. With Dr. Kelly's leadership and expertise, Oragenics is poised to make significant strides in the treatment of mild TBI and potentially improve the lives of millions of patients affected by concussions and related neurological disorders.