Oragenics Appoints James Kelly MD, Chief Medical Officer, to Lead Phase II Clinical Trials for Treating Concussion

Rhea-AI Summary

Oragenics, Inc. (OGEN) appoints Dr. James Kelly as Chief Medical Officer for upcoming Phase II clinical trial of ONP-002, a drug candidate for mild Traumatic Brain Injury. Dr. Kelly brings extensive experience in treating brain injuries and will lead the drug trials to improve patient outcomes.

Insights

Neuroscience Expert

The appointment of Dr. James Kelly as Chief Medical Officer at Oragenics signifies a strategic move to enhance the company's clinical trial leadership, specifically for the Phase II trial of ONP-002. Dr. Kelly's extensive background in treating traumatic brain injuries (TBI), combined with his experience with the FDA and clinical trials, brings a level of expertise that is likely to be advantageous for the trial's design and execution. This could lead to more robust data collection and potentially a higher likelihood of successful outcomes.

Dr. Kelly's advocacy for early intervention in brain injuries underscores the importance of ONP-002's target to address inflammation and oxidative stress, which are critical factors in the progression of TBI. The drug's mechanism, aiming to protect the brain immediately after injury, could represent a significant advancement in TBI treatment protocols. Given the high incidence of concussions and their potential to lead to long-term disabilities, a successful treatment could have substantial implications for patient care and healthcare costs.

Pharmaceutical Development Expert

Oragenics' focus on completing drug manufacturing and formulation at Good Manufacturing Practice (GMP) facilities is a testament to the company's commitment to maintaining high-quality standards throughout the drug development process. This attention to detail is important for ensuring the integrity of ONP-002 before and during clinical trials, which is a key factor in the drug's potential market approval and eventual commercial success.

The preclinical success of ONP-002 in animal models, particularly its ability to improve molecular and behavioral outcomes post-injury and enhance brain exposure when delivered intranasally, sets a positive precedent for the upcoming human trials. If these effects translate effectively to humans, it could position ONP-002 as a significant player in the TBI treatment market, addressing a critical unmet medical need.

Market Analyst

The global concussion market is vast, with an estimated 69 million concussions reported annually. The development of a successful treatment for TBI could tap into this extensive market, offering substantial financial benefits to Oragenics. However, the road to market approval is fraught with challenges, including rigorous regulatory hurdles and the need for robust clinical evidence to support efficacy and safety claims.

Investors should monitor Oragenics' progress closely, as positive results from the Phase II trial could lead to increased investor confidence and potentially boost the company's stock value. Conversely, any setbacks could have a negative impact on the company's financial health. The long-term potential of ONP-002, should it prove successful, could also attract partnership opportunities, licensing deals, or even acquisition interest from larger pharmaceutical companies looking to expand their neurology portfolios.

SARASOTA, Fla.--(BUSINESS WIRE)-- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced it has appointed Dr. James “Jim” Kelly, Neurologist, as its Chief Medical Officer, to oversee its upcoming Phase II clinical trial. Oragenics’ lead drug candidate, ONP-002 is combined with its intranasal device intended for the treatment of mild Traumatic Brain Injury (TBI), aka concussion. ONP-002 is a new chemical entity (NCE) designed to target the brain through delivery into the nasal cavity and onward to the brain. A 40-patient Phase I study was completed and showed the drug to be safe and well-tolerated.

In the recent past, Dr. Kelly served as the Executive Director of the Marcus Institute for Brain Health (MIBH) and Professor of Neurology at the University of Colorado Anschutz Medical Campus in Aurora, Colorado. The MIBH specialized treatment program is funded by the Marcus Foundation to care for US military veterans with persistent symptoms of TBI. Dr. Kelly was also National Director of the Avalon Action Alliance TBI Programs for which the MIBH serves as the clinical coordinating center.

“I am excited to join Oragenics as its Chief Medical Officer at such an important and pivotal time in the drug development process. I have been involved with the drug for many years now and look forward to testing the drug and showing it can improve patient outcomes in our upcoming Phase II clinical trials,” said Dr. Kelly.

Prior to these recent positions, Dr. Kelly was the Director of the National Intrepid Center of Excellence (NICoE) at Walter Reed National Military Medical Center in Bethesda, MD. As its founding Director, he led the creation of an innovative interdisciplinary team of healthcare professionals who blended high-tech diagnosis and treatment with complementary and alternative medical interventions in a holistic, integrative approach to the care of US military personnel with the complex combination of TBI and psychological conditions, such as post-traumatic stress, depression, and anxiety. In this role, Dr. Kelly was frequently called upon by leaders of the Military Health System at the Pentagon, the US Congress, the Department of Veterans Affairs, and numerous military facilities in the continental US and abroad. Dr. Kelly has interacted with the FDA and clinical trials for brain injury throughout his esteemed career. He is a strong advocate for treatments in the acute phase of brain injury and understands the value of protecting the brain early on from inflammation, swelling and oxidative stress to gain better clinical outcomes.

“We are fortunate to have such an esteemed neurologist as Dr. Kelly join our team in this important role at Oragenics. Dr. Kelly is recognized as a leading expert in concussion and other brain injuries and we are fortunate to have him lead our drug trials going forward. We are currently completing the drug manufacturing and formulation at GMP facilities to ensure the integrity of the drug before and during the trials, and we look forward to completing this work in the short-term and getting the Phase II trial underway,” stated Michael Redmond, President of Oragenics.

In preclinical animal models, the drug has been shown to acutely improve molecular and behavioral outcomes following brain injury. In addition, intranasal delivery of the drug as a nanoparticle has been shown to enhance brain exposure and metabolism in animals. “Our Phase I human study has shown ONP-002 to be well tolerated in humans. Our mission now is to show that the ONP-002 brain protective mechanisms in animals translates to humans. Our Phase II study is designed to establish time to first dose, relationships between drug application and blood biomarkers, and the evaluation of clinical endpoints to determine improved in patient outcomes, ” said Dr. Kelly.

Concussion is an unmet medical need. There is an estimated 69 million concussions annually reported worldwide. Common causes of concussion include falls, motor vehicle accidents, and contact sports. Other neurological disorders including Alzheimer’s Disease, Parkinson’s Disease and Chronic Traumatic Encephalopathy (CTE) have been linked to concussion. Post concussion syndrome is linked to long term disability and occurs in as high as 20% of concussed patients.

Forward-Looking Statements

This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the ability of the Company to timely and successfully undertake the Phase II clinical trial using its novel drug - device combination for the treatment of mild Traumatic Brain Injury. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words "believe," "expect," "anticipate," "intend," "estimate," "project" and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: the Company’s ability to advance the development of its product candidates, including the neurology assets, under the timelines and in accord with the milestones it projects; the Company’s ability to retain its key employees and independent contractors necessary to continue to develop its product candidates and in particular ONP-002 and the availability of those key employees and independent contractors; the Company’s ability to raise capital and obtain funding, non-dilutive or otherwise, for the development of its product candidates; the Company’s expectations as to the outcome of the Phase II clinical trial and the potential benefits, activity, effectiveness and safety of its product candidates including as to administration, transmission, manufacturing, storage and distribution; and general economic and market conditions and risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth is as of the date hereof unless otherwise indicated. You should consider these factors in evaluating the forward-looking statements included and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law.

Released March 18, 2024

View source version on businesswire.com: https://www.businesswire.com/news/home/20240318916780/en/

Oragenics, Inc.

Janet Huffman, Chief Financial Officer

813-286-7900

jhuffman@oragenics.com

LHA Investor Relations

Tirth T. Patel

212-201-6614

tpatel@lhai.com

Source: Oragenics, Inc.

FAQ

Who has Oragenics appointed as its Chief Medical Officer for the Phase II clinical trial of ONP-002?

Oragenics has appointed Dr. James Kelly as its Chief Medical Officer for the Phase II clinical trial of ONP-002.

What is the lead drug candidate of Oragenics for the treatment of mild Traumatic Brain Injury?

Oragenics' lead drug candidate for the treatment of mild Traumatic Brain Injury is ONP-002.

What was the outcome of the Phase I study of ONP-002?

The Phase I study of ONP-002 showed the drug to be safe and well-tolerated.

What are some of the neurological disorders linked to concussion?

Neurological disorders linked to concussion include Alzheimer’s Disease, Parkinson’s Disease, and Chronic Traumatic Encephalopathy (CTE).

How many concussions are estimated annually worldwide?

There are an estimated 69 million concussions reported annually worldwide.