Oragenics, Inc. Preparing for Phase II Clinical Trials to Treat Concussion
February 05 2024 - 8:00AM
Business Wire
Oragenics, Inc. (NYSE American: OGEN), a company focused on
developing unique, intranasal nanoparticle pharmaceuticals for the
treatment of neurological disorders, today announced it is
preparing for a Phase II clinical trial using its novel drug -
device combination 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. A
40-patient Phase I study showed ONP-002 to be safe and
well-tolerated.
Oragenics has begun the final process of synthesizing and
formulating the drug needed for its Phase II clinical trial. It is
expected that enrolled patients will be in the acute phase
following concussions, after diagnosis the patient will quickly
receive their first dose intranasally.
“Concussion is a serious unmet medical need. An acute treatment
that can mitigate the pathological cascade could help so many
people. We are excited to get the Phase II clinical trials
underway,” commented Dr. James “Jim” Kelly, Neurologist and
Executive Director of the Marcus Institute of Brain Health and an
advisor on the planned phase II trial.
ONP-002 has been shown to have a neuroprotective molecular
profile and improve behavioral outcomes including memory and motor
performance in animal models of brain injury. The drug has a large
safety margin between dosages used in the animal toxicology program
and those used in the Phase I study and planned for the upcoming
Phase II clinical trial. Intranasal delivery of ONP-002 as a
nanoparticle has been shown to enhance brain exposure in animals.
“Intranasal delivery targeting the brain is our model for improving
brain health while maintaining a strong safety margin,” 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.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240201607311/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
Oragenics (AMEX:OGEN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Oragenics (AMEX:OGEN)
Historical Stock Chart
From Apr 2023 to Apr 2024