Oragenics, Inc. Prepares Drug for Phase II Clinical Trials to Treat Concussion
March 05 2024 - 7:45AM
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
Oragenics (AMEX:OGEN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Oragenics (AMEX:OGEN)
Historical Stock Chart
From Jul 2023 to Jul 2024