Oragenics Develops Automated Intranasal Device for Treating Concussed Patients
June 27 2024 - 8:30AM
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 10% of concussed patients lose
consciousness, while many others experience an immediate altered
mental state, with short-term memory loss and confusion. Both loss
of consciousness and acute memory impairment are linked to
prolonged post-concussion symptoms and poor clinical outcomes.
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 20% of concussed patients.
About
Oragenicswww.oragenics.com
Forward-Looking StatementsThis
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
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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
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our filings with the U.S. Securities and Exchange Commission. All
information set forth is as of the date hereof unless otherwise
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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
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required by law.
Oragenics, Inc.Janet Huffman, Chief Financial
Officer813-286-7900jhuffman@oragenics.com
Investor Relations:Rich CockrellCG
Capital404-736-3838ogen@cg.capital
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