Oragenics Develops Automated Intranasal Device for Treating Concussed Patients
Oragenics (NYSE American: OGEN) has announced the development of an automated intranasal device for treating concussed patients. The new prototype is designed for initial use in acute settings where patients are confused, dazed, or unconscious. Oragenics' lead drug candidate, ONP-002, aims to target the brain through nasal delivery. A Phase II study will evaluate ONP-002's effectiveness on blood biomarkers and patient-reported outcomes. The automated device is particularly intended for patients unable to self-administer the drug due to mental impairment. Concussions, affecting around 69 million people annually, often result from falls, motor vehicle accidents, and contact sports.
- Development of an automated intranasal device for initial treatment of concussed patients.
- Planned Phase II study to evaluate ONP-002’s effectiveness.
- Targeting a large market with 69 million concussion cases reported annually.
- The need for an automated device indicates that many patients might have difficulty using the existing breath-propelled version.
The development of an automated intranasal device by Oragenics for treating concussed patients marks a significant step forward in addressing acute neurological trauma. Typically, concussed patients often face immediate cognitive impairments, complicating the administration of necessary treatments. By creating a device that automates this process, Oragenics is potentially improving the immediate care for patients who are confused, dazed, or unconscious. Such advancements in medical technology can lead to quicker intervention, potentially reducing long-term neurological damage.
Importantly, this device aims to administer ONP-002, a new chemical entity (NCE) targeting the brain through nasal delivery. The Phase II study focusing on blood biomarkers and patient-reported outcomes will be important in determining the efficacy of ONP-002 in improving clinical outcomes. The automated device ensures that even those unable to follow instructions can receive timely treatment, which could translate to better recovery rates and lower long-term complications.
From a medical innovation standpoint, the automated intranasal device could shift the paradigm in acute concussion management. However, the clinical success of ONP-002 in Phase II trials remains pivotal. If successful, this innovation could significantly differentiate Oragenics in the neuroscience drug development landscape.
Oragenics' new device and its lead drug candidate, ONP-002, have the potential to address a highly unmet medical need in concussion treatment. With an estimated 69 million concussions occurring annually worldwide and up to 20% resulting in prolonged symptoms, the market for reliable concussion management solutions is substantial. The automated intranasal device can offer a competitive advantage, particularly in a market where effective treatments are scarce.
The company's focus on both the automated and breath-propelled intranasal delivery systems allows it to cater to a broader patient demographic, which could enhance adoption rates among healthcare providers. Moreover, the planned Phase II study, if positive, will likely bolster investor confidence and attract strategic partnerships or acquisition opportunities.
However, the market acceptance of these devices will depend on their clinical trial results and subsequent regulatory approvals. Successful outcomes will not only validate the technology but also open up significant commercial opportunities in the concussion management space, potentially driving shares upwards in the long term.
Oragenics' new automated intranasal device, in conjunction with its Phase II trial for ONP-002, can be a catalyst for future growth. The advancement addresses a critical gap in the treatment of concussed patients, particularly those with immediate cognitive impairments. From a financial perspective, the prototype's successful development and potential FDA approval can significantly impact Oragenics' revenue streams.
Investors should look out for the Phase II trial results, as positive data could validate the technology and lead to commercial viability. Given the high incidence of concussions and the current lack of effective acute treatments, the market potential is considerable. Furthermore, advancements in the device can lead to increased investor confidence and potential upward movement in stock prices.
However, it is essential to remain cautious until more concrete data is available. Any setbacks in clinical trials or regulatory hurdles could impact the financial outlook negatively. Therefore, while the current development is promising, investors should monitor clinical progress closely.
The device is intended for initial treatment in the acute setting
SARASOTA, Fla., June 27, 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 completed a prototype of its automated intranasal device for use in concussed patients who are initially confused, dazed or unconscious in the acute phase of injury. Oragenics’ lead drug candidate, 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 is being designed to analyze the effectiveness of ONP-002 on blood biomarkers and patient-reported outcomes of concussed patients.
Loss of consciousness along with acute memory impairment are linked to prolonged post-concussion symptoms and poor clinical outcomes. Oragenics’ breath-propelled device requires the patient to administer ONP-002 into the nose. Concussed patients with an acute altered mental state may not be capable of following these instructions. Oragenics intends to use its breath-propelled device in the planned Phase II trial, which calls for multiple days of treatment. However, for those patients who have a loss of consciousness or altered mental status early on, the current automated prototype is being developed for their initial treatment by medical staff during the period in which they may struggle to follow directions for blowing.
“We are excited about this new automated technology as it allows us to treat the full range of concussive injuries. Both devices offer advantages and can deliver our nanoparticle powder. Given the early mental alterations many concussed patients experience, we aim to provide them the best drug delivery route to improve their clinical outcomes,” stated Michael Redmond, President at Oragenics.
Approximately
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 symptomology is linked to long-term disability and occurs in as high as
About Oragenics
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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