Oragenics, Inc. Prepares Drug for Phase II Clinical Trials to Treat Concussion

Rhea-AI Summary

Oragenics, Inc. (OGEN) announces final steps for GMP manufacturing and formulation of its drug candidate ONP-002 for Phase IIA clinical trial targeting mild Traumatic Brain Injury. The drug, combined with a novel intranasal device, aims to deliver treatment directly to the brain. A 40-patient Phase I study showed ONP-002 to be safe. Oragenics is manufacturing the Active Pharmaceutical Ingredient to be formulated as a nanoparticle powder for intranasal delivery. The company aims to recruit Phase II patients aged 18-55 in the acute phase following concussion, addressing the unmet medical need of concussions affecting 69M people annually worldwide.

Insights

Pharmaceutical Research Analyst

The commencement of Good Manufacturing Practice (GMP) manufacturing and formulation of Oragenics' drug candidate, ONP-002, marks a critical juncture in the drug development process. This step is essential for ensuring that the drug candidate is produced consistently, safely and to the required quality standards before advancing to a Phase IIA clinical trial. The focus on mild Traumatic Brain Injury (TBI), an area with significant unmet medical needs, could have profound implications for the company's valuation if the drug shows efficacy in human trials.

From a pharmaceutical research perspective, the novelty of both the drug candidate and the intranasal delivery device could offer a competitive edge in the TBI treatment market. The safety and tolerability demonstrated in the initial human study are promising, but the efficacy in treating concussions will be pivotal. The success in Phase II trials will likely influence investor confidence and could lead to partnerships or funding opportunities for Oragenics.

Medical Device Analyst

Oragenics' development of a novel intranasal device for drug delivery is noteworthy in the context of medical device innovation. The approach of targeting olfactory nerve beds for direct brain delivery is a sophisticated technique that may enhance the drug's effectiveness while potentially reducing systemic side effects. The device's design as an acute field deliverable aligns with the immediate treatment requirements post-concussion, which could significantly benefit patient outcomes if proven effective.

Investors and stakeholders in the medical device sector should monitor the progress of this device, as its success could disrupt the current treatment protocols for concussions and similar neurological disorders. The scalability and patentability of such a device could also create additional revenue streams for Oragenics beyond the drug itself.

Healthcare Market Analyst

The global incidence of concussions, estimated at 69 million annually, underscores the substantial market potential for effective treatment options. Oragenics' focus on a self-propelled powdered delivery system for ONP-002 could meet a significant demand within this market, especially considering the link between concussions and other neurological disorders like Alzheimer's and Parkinson's Disease.

Given the high prevalence of post-concussion syndrome and the potential for long-term disability, a successful treatment could lead to considerable market share and revenue growth. Furthermore, the company's targeting of patients in the acute phase following concussion aligns with current medical understanding of the importance of early intervention. The healthcare market will closely watch the outcomes of the Phase II trial for indications of the drug's commercial viability.

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 is preparing to undertake the final steps of GMP manufacturing and formulation of its drug candidate for its expected Phase IIA clinical trial. The drug candidate is expected to be combined with its novel intranasal device, for the treatment of mild Traumatic Brain Injury, aka concussion. Oragenics’ lead drug candidate, ONP-002, is a new chemical entity (NCE) designed to target the brain through self-propelled powdered delivery into the nasal cavity and onward to the brain. A 40-patient Phase I human study showed ONP-002 to be safe and well-tolerated.

Oragenics is currently manufacturing the Active Pharmaceutical Ingredient (API) that will then be formulated and spray dried as a nanoparticle powder. Once formulated the powder is loaded into an intranasal device, believed to be novel, that is breath-propelled, which Oragenics believes will improve intranasal binding to the olfactory nerve beds for delivery directly to the brain. This application, believed to be novel, is designed as an acute field deliverable, intended to allow for concussed patients to get treatment in the early stages when the pathological cascade is most intense. Phase II patients will be recruited between the ages of 18-55 in the acute phase following concussion.

Intranasal delivery of ONP-002 as a nanoparticle has been shown to enhance brain exposure and metabolism in animals. “Preclinical intranasal targeting of the brain has been shown to improve outcomes in animals and safety margin following concussion. We are excited to be finishing up ONP-002 manufacturing and formulation work needed for our Phase II study which is on the horizon,” commented Michael Redmond, President of Oragenics.

Concussion is an unmet medical need. There is an estimated 69M 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. “Concussions can have serious long-term consequences. Manufacturing and formulating API in a GMP facility ensures the integrity of the drug before and during the trials, we look forward to completing this work in the short-term and getting the Phase II trial underway,” Greg Gironda, Oragenics Operational Consultant.

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 a 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240305110200/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

What is the drug candidate being developed by Oragenics for the Phase IIA clinical trial targeting mild Traumatic Brain Injury?

Oragenics is developing the drug candidate ONP-002 for the Phase IIA clinical trial targeting mild Traumatic Brain Injury.

What was the outcome of the 40-patient Phase I study for ONP-002?

The 40-patient Phase I study showed ONP-002 to be safe and well-tolerated.

How does Oragenics plan to deliver the drug candidate to the brain?

Oragenics plans to deliver the drug candidate to the brain through intranasal delivery using a novel intranasal device.

What is the target age range for Phase II patients in the study?

Phase II patients aged between 18-55 in the acute phase following concussion will be recruited for the study.

What is the estimated number of concussions reported annually worldwide?

There is an estimated 69 million concussions reported annually worldwide.