Oragenics, Inc. Prepares Intranasal Pharmaceutical, ONP-002, for Phase II Concussion Trial
Oragenics (NYSE American: OGEN) announced preparations for a Phase II clinical trial of its lead drug candidate, ONP-002, designed to treat mild Traumatic Brain Injury (mTBI). The trial will focus on intranasal delivery for rapid brain targeting, bypassing the blood-brain barrier. Oragenics has optimized the drug formulation and secured intranasal devices, partnering with Avance Clinical to implement the trial in emergency departments of level one trauma centers. Preclinical studies showed promising results in brain injury outcomes, and Phase I trials confirmed ONP-002's tolerability in humans. Concussions, a significant global health issue, often lead to long-term neurological disorders, highlighting the need for effective treatments like ONP-002.
- Preparing for Phase II clinical trial of ONP-002, targeting mTBI treatment.
- Improved formulation of ONP-002 for better intranasal absorption and brain targeting.
- Secured sufficient supply of intranasal devices for the trial.
- Partnership with Avance Clinical to implement Phase II trial in top trauma centers.
- Preclinical studies show ONP-002 improves molecular and behavioral outcomes post-brain injury.
- Phase I trials confirm ONP-002 is well tolerated in humans.
- The success of ONP-002 in Phase II trials is still uncertain.
- No mention of specific timelines for the Phase II trial start or completion.
ONP-002 for treating mild Traumatic Brain Injury (mTBI) represents a significant step forward in addressing a critical unmet need in neurology. This condition affects millions annually and lacks effective treatments. Intranasal administration as a delivery method is particularly noteworthy because it bypasses the blood-brain barrier — a major hurdle in neurological drug delivery. The ability to ensure rapid absorption and targeted drug delivery to the brain presents a unique advantage over traditional methods.
Preclinical and Phase I studies have shown that ONP-002 is well tolerated and effective in enhancing brain exposure, suggesting a promising profile for further development. The focus on increasing the active compound and optimizing particle size indicates rigorous efforts to improve efficacy and safety.
Given the prevalence and severity of concussion-related complications like Alzheimer's and Chronic Traumatic Encephalopathy (CTE), a successful Phase II trial could potentially transform the treatment landscape for mTBI. However, investors should stay attentive to the outcomes of the trial to assess long-term prospects accurately.
The collaboration with Avance Clinical Pty Ltd, a renowned Clinical Research Organization (CRO), is a strategic move to ensure a robust and well-structured Phase II clinical trial. Conducting the trial in level one trauma centers, which specialize in acute care, will likely provide high-quality data and enhance the study's credibility. These centers are well-equipped to handle the complexities of such trials, potentially leading to more accurate and reliable results.
Moreover, securing an adequate supply of intranasal devices demonstrates thorough planning and readiness, which is important for the trial's seamless execution. Investors should note that Phase II trials are often pivotal for determining the drug's efficacy and safety profile in a larger population, making this a critical phase in ONP-002's development journey.
From a financial perspective, Oragenics' progress with ONP-002 could enhance the company's valuation significantly if the Phase II trial proves successful. The global market for mTBI treatments remains largely untapped and a successful drug could capture a substantial market share, translating to significant
However, investors should consider the costs associated with clinical trials and the subsequent commercialization process. Partnerships with experienced CROs and securing supplies indicate a well-thought-out strategy, but the financial sustainability will depend on continued funding and successful trial outcomes. Short-term volatility is expected as trial results unfold, but the long-term potential remains attractive.
SARASOTA, Fla., May 16, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a pioneering pharmaceutical company specializing in intranasal treatments for neurological disorders, today announced an update on the company and its drug development program. Oragenics is designing an upcoming Phase II clinical trial conducted in acute and emergency departments. The company is preparing to initiate a Phase II clinical trial for its lead drug candidate, ONP-002, an innovative neurosteroid designed to treat mild Traumatic Brain Injury (mTBI), commonly referred to as concussion.
Advancements in Drug Formulation for Phase II Trial
Oragenics is focused on enhancing the formulation of ONP-002 by increasing the percentage of active compound in the final spray-dried intranasal powder. The formulation improvements aim to optimize the size of the emitted particles, ensuring they are large enough to prevent deep lung inhalation while maximizing intranasal absorption and brain targeting. This intranasal delivery method is crucial for bypassing the blood-brain barrier, facilitating rapid and efficient drug delivery to the brain within minutes.
Clinical Trial Preparations
In preparation for the Phase II clinical trial, Oragenics has secured an adequate supply of intranasal devices. The company has also partnered with Avance Clinical Pty Ltd, a renowned Clinical Research Organization (CRO) based in Adelaide, Australia. This collaboration will facilitate the implementation of the Phase IIa trial in emergency departments at level one trauma centers, which Oragenics anticipates will result in a robust and well-structured study.
Leadership Insights
“We are privileged to collaborate with exceptional GMP pre-clinical research teams dedicated to optimizing our drug formulation and intranasal device components,” stated Michael Redmond, President of Oragenics. "Our continued partnership with Avance Clinical has been instrumental in ensuring a seamless transition into our Phase II clinical trial.”
Preclinical studies have demonstrated that ONP-002 significantly improves molecular and behavioral outcomes following brain injury. Additionally, intranasal delivery of ONP-002 as a nanoparticle has shown enhanced brain exposure and metabolism, underlining the potential of this innovative treatment.
Dr. James Kelly, Chief Medical Officer of Oragenics, added, “Our Phase I human study has confirmed that ONP-002 is well tolerated in humans. We are encouraged by the progress and support we have received in optimizing our program, setting the stage for the launch of our Phase II trials.”
Addressing an Unmet Medical Need
Concussion remains an unmet medical need, with an estimated 69 million cases reported globally each year. Common causes include falls, motor vehicle accidents, and contact sports. Concussions are also associated with long-term neurological disorders such as Alzheimer's Disease, Parkinson's Disease, and Chronic Traumatic Encephalopathy (CTE). Post-concussion syndrome, which can lead to long-term disability, affects up to
Oragenics remains committed to advancing its groundbreaking intranasal pharmaceutical solutions, aiming to provide effective treatments for neurological disorders and to improve patient outcomes worldwide.
About Oragenics, Inc.
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 trials 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
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