Oragenics Improves Intranasal Drug Formulation for Treating Concussed Patients
Oragenics has developed a new formulation for its neurosteroid, ONP-002, designed for treating concussions via intranasal delivery. The formulation aims to enhance brain uptake and bioavailability, leading to longer absorption times. A Phase II study is planned to evaluate the drug's safety and effectiveness in concussed patients by examining blood biomarker profiles and functional outcomes. The improved formulation is part of Oragenics' platform for acute-field drug delivery, with the goal of reducing immediate and long-term concussion symptoms. Concussion, affecting 69 million people annually worldwide, is linked to various severe neurological disorders.
- Development of a new, improved intranasal drug formulation for ONP-002.
- Enhanced bioavailability and longer absorption times for the drug.
- Phase II study planned to assess drug safety and effectiveness in concussed patients.
- No conclusive effectiveness data available as the study is still in the planning stage.
- Potential risks associated with the new formulation are not yet disclosed.
Insights
Oragenics’ announcement of an improved formulation for its neurosteroid ONP-002 might be a significant development in the field of concussion treatment. Concussions are a major concern in public health due to their high prevalence and potential for severe long-term effects.
The company's focus on intranasal delivery is noteworthy because this method can bypass the blood-brain barrier, which is a significant challenge in delivering drugs to the brain. The enhanced bioavailability and longer absorption times mentioned indicate that the drug could potentially be more effective in reaching therapeutic levels in the brain.
However, it's important to consider that the development is still at an early stage, with a Phase II study being planned. Although the initial improvements in the drug's formulation are encouraging, the real test will be the clinical trials that will assess its safety and effectiveness in patients. There is a gap between laboratory success and clinical efficacy that needs to be bridged.
Additionally, the market for concussion treatments is substantial, given the high incidence of concussions globally. If ONP-002 proves effective, it could address a significant unmet medical need and capture a considerable market share. However, investors should be mindful of the inherent risks and uncertainties associated with drug development and clinical trials.
From a financial perspective, Oragenics' development of an improved formulation for ONP-002 could have potential implications for the company’s valuation. The ability to improve drug delivery and bioavailability is important for gaining a competitive edge in the pharmaceutical market, particularly in treating neurological disorders.
Investors should keep an eye on the upcoming Phase II study, as positive results could lead to increased investor confidence and potentially drive up the stock price. The company’s ability to move from development to a successful clinical trial phase will be key to unlocking further investments and partnerships.
It's also important to consider Oragenics' current financial health and how well it can fund continued research and development. Companies in the biotech sector often face significant expenditures before any revenue can be realized from new drugs. Therefore, understanding Oragenics' financial runway and capital-raising strategies will be essential for assessing the investment potential.
Lastly, the size of the market opportunity is notable. With an estimated 69 million concussions annually worldwide, a successful treatment could mean substantial revenue. However, the company will need to navigate regulatory hurdles and competition from other treatments and technologies in the market.
Formulation designed to enhance brain uptake
SARASOTA, Fla., July 10, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced it has developed a new formulation for its novel neurosteroid. Oragenics’ lead drug candidate for 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 Phase II study in concussed patients is being planned to assess safety and feasibility while analyzing the drug’s effectiveness based on patient blood biomarker profiles and functional outcomes.
Oragenics believes the nasal cavity provides access for Oragenics’ novel neurosteroid formulation to enter the brain in minutes. Given the difficulty of getting neurosteroids into solution, unique formulations must be developed to achieve therapeutic levels. Oragenics believes that its recent work has increased the final dose levels significantly while also providing for improved intranasal drug adhesion and, thus, longer absorption times. Oragenics believes it has successfully completed an improved formulation of ONP-002 that should significantly increase the bioavailability of the intranasal drug formulation. The enhanced drug percentages in this novel formulation have been developed by Oragenics as part of its platform for acute-field delivery of the drug. Oragenics’ newly developed intranasal drug formulation is intended to reduce the duration of initial concussion symptoms and prevent long-lasting symptoms that can be debilitating after a concussion.
“We are thrilled about the recent modifications to our novel intranasal drug formulation. Anything that can be done to drive more chemical protection to the brain during the acute pathological cascade will help reduce negative outcomes in the concussed population,” stated Dr. James Kelly, Chief Medical Officer at Oragenics.
Concussion is a serious unmet medical need. There are an estimated 69 million concussions annually reported worldwide. Common causes of concussion include falls, motor vehicle accidents, military incidents, 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 symptomology is linked to long-term disability and occurs in as high as
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 intranasal formulations and intranasal devices for delivering the intranasal formulations. 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
Investor Relations:
Rich Cockrell
CG Capital
404-736-3838
ogen@cg.capital
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