Oragenics Partners with Avance Clinical for Phase II Concussion Trial in Australia

Rhea-AI Summary

Oragenics, Inc. partners with Avance Clinical for a Phase II clinical trial in Australia to evaluate ONP-002 for mild Traumatic Brain Injury (TBI). The partnership aims to address the significant unmet medical need for concussion treatment through innovative intranasal pharmaceuticals. Oragenics' lead drug candidate, ONP-002, has shown promise in a Phase I trial and is delivered through a unique intranasal device designed for direct brain delivery. Avance Clinical's expertise in managing clinical trials in Australia, New Zealand, and North America brings valuable experience to the collaboration, highlighting the potential for future concussion treatment protocols.

Positive

• Successful completion of Phase I clinical trial in Australia demonstrating safety and tolerability of ONP-002.

• Partnership with Avance Clinical, a well-established Contract Research Organization with over two decades of experience in clinical trial management.

• ONP-002 designed for direct brain delivery through a unique intranasal device, offering a novel approach to treating mild Traumatic Brain Injury.

Negative

• Concussion is a prevalent condition with an estimated 69 million cases reported annually worldwide, highlighting the vast scope of the medical need.

• Post-concussion syndrome, linked to long-term disability, affects up to 20% of concussed patients, indicating the severity of potential complications.

Medical Research Analyst

The collaboration between Oragenics and Avance Clinical signifies a noteworthy advancement in the therapeutic area targeting neurological disorders such as mild Traumatic Brain Injury (TBI). The progression to a Phase II clinical trial marks a pivotal step in the development of ONP-002. A successful Phase II trial can demonstrate efficacy and further safety, which is critical for the drug's eventual market approval. For investors, the therapeutic area of concussion represents a significant market opportunity due to the high global incidence of TBIs. A novel intranasal delivery mechanism has a potential competitive advantage by ensuring targeted drug delivery to the brain, which may increase the drug's effectiveness while potentially reducing systemic side effects. Investors should monitor the trial outcomes, as positive results could be a catalyst for stock appreciation, while any setbacks could adversely affect the company's valuation.

Financial Analyst

Investing in biotech firms like Oragenics involves assessing the risk/reward balance of clinical trials' outcomes. The safe and well-tolerated results from the Phase I trial add confidence to investor perceptions but do not ensure Phase II success. The costs associated with clinical trials are substantial and the funding requirements often lead to capital raises, which can dilute current shareholders' stakes. However, successful Phase II results could increase the likelihood of strategic partnerships or buyout offers from larger pharmaceutical companies interested in expanding their neurology portfolio. Long-term, if ONP-002 reaches market, it could meet a substantial unmet need in the concussion space, potentially leading to strong revenue streams for Oragenics. The Australian connection, with its expertise in clinical trial management, may also provide an expedient regulatory path, benefiting time-to-market strategies.

Market Research Analyst

The choice of Australia for the Phase II trial is strategic, highlighting a region with a high incidence of sports-related concussions. This not only allows for a robust participant pool but also showcases Oragenics' international collaborative capabilities. The growing awareness of TBI's long-term effects, such as CTE and post concussion syndrome, underline the societal and economic importance of effective treatments. Therefore, the market for a successful treatment is potentially vast, reaching beyond immediate healthcare savings to impact labor markets and insurance sectors. Assuming ONP-002 is successful, it would tap into a market that is currently underserved, promising substantial returns for early investors. The medical community's emphasis on head injury treatment in Australia can facilitate rapid adoption if the drug is approved, contributing to quicker revenue generation.

SARASOTA, Fla., May 07, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a pioneer in developing innovative intranasal pharmaceuticals for neurological disorders, today announced a partnership with Avance Clinical, a leading Contract Research Organization (CRO), to conduct a Phase II clinical trial in Australia. This trial aims to evaluate Oragenics' lead drug candidate, ONP-002, for mild Traumatic Brain Injury (TBI), commonly known as concussion. ONP-002, a novel chemical entity (NCE), is delivered through a unique intranasal device and designed to maximize drug delivery directly to the brain.

Avance Clinical, renowned for its clinical trial management capabilities and quality of service in Australia, New Zealand, and North America, brings over two decades of expertise in navigating the Therapeutic Goods Administration, Food and Drug Administration, and European Medicines Agency regulatory landscapes. An Oragenics Phase I clinical trial, recently completed in Australia under the management of Avance Clinical, demonstrated that ONP-002 is safe and well-tolerated.

"Concussion remains a significant unmet medical need," said Dr. Jorgen Mould, Senior Director of Scientific and Regulatory Services at Avance Clinical. "Oragenics is poised to address this challenge, and we are delighted to be part of the team, especially given Australia's high incidence of sports-related concussions."

Michael Redmond, President of Oragenics, added, "Our collaboration with Avance Clinical during the Phase I trial was instrumental, and we are confident in their ability to execute an effective Phase II trial that will pave the way for future treatment protocols for concussion."

Dr. James Kelly, Neurologist and Chief Medical Officer at Oragenics, emphasized the critical role of the Australian medical community: "Australia has been at the forefront of diagnosing and treating head injuries. We are fortunate to work with such skilled medical professionals in conducting this pivotal research."

Concussion is an unmet medical need. There are 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.

About Oragenics

Oragenics is a development-stage biotechnology company focused on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases, including drug candidates for treating mild traumatic brain injury (mTBI), also known as concussion, and for treating Niemann Pick Disease Type C (NPC), as well as proprietary powder formulation and an intranasal delivery device. For more information, please visit www.oragenics.com.

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 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 raise capital and obtain funding, non-dilutive or otherwise, for the development of its product candidates; the regulatory application process, research and development stages, and future clinical data and analysis relating to its product candidates, including any meetings, decisions by regulatory authorities, such as the FDA and investigational review boards, whether favorable or unfavorable; the Company’s ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the nature of competition and development relating to concussion treatments; the Company’s expectations as to the outcome of preclinical studies and clinical trials 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.

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

 

FAQ

What is the purpose of the partnership between Oragenics and Avance Clinical?

The partnership aims to conduct a Phase II clinical trial in Australia for evaluating ONP-002 as a treatment for mild Traumatic Brain Injury (TBI).

What is the significance of ONP-002 in the Phase II trial?

ONP-002 is a novel chemical entity designed for direct brain delivery through an intranasal device, offering a unique approach to addressing concussion.

What did the Phase I trial in Australia demonstrate about ONP-002?

The Phase I trial confirmed the safety and tolerability of ONP-002, paving the way for further clinical development in the Phase II trial.

How prevalent is concussion as a medical condition?

Approximately 69 million concussions are reported worldwide annually, indicating a significant unmet medical need for effective treatments.

What complications are associated with post-concussion syndrome?

Post-concussion syndrome can lead to long-term disability and affects up to 20% of concussed patients, highlighting the severity of potential consequences.