Oragenics Improves Intranasal Drug Formulation for Treating Concussed Patients
July 10 2024 - 8:00AM
Oragenics, Inc. (NYSE American: OGEN), a company focused on
developing unique, intranasal pharmaceuticals for the treatment of
neurological disorders, today announced it has developed a new
formulation for its novel neurosteroid. Oragenics’ lead drug
candidate for concussion, 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 in concussed patients is
being planned to assess safety and feasibility while analyzing the
drug’s effectiveness based on patient blood biomarker profiles and
functional outcomes.
Oragenics believes the nasal cavity provides
access for Oragenics’ novel neurosteroid formulation to enter the
brain in minutes. Given the difficulty of getting neurosteroids
into solution, unique formulations must be developed to achieve
therapeutic levels. Oragenics believes that its recent work has
increased the final dose levels significantly while also providing
for improved intranasal drug adhesion and, thus, longer absorption
times. Oragenics believes it has successfully completed an improved
formulation of ONP-002 that should significantly increase the
bioavailability of the intranasal drug formulation. The enhanced
drug percentages in this novel formulation have been developed by
Oragenics as part of its platform for acute-field delivery of the
drug. Oragenics’ newly developed intranasal drug formulation is
intended to reduce the duration of initial concussion symptoms and
prevent long-lasting symptoms that can be debilitating after a
concussion.
“We are thrilled about the recent modifications
to our novel intranasal drug formulation. Anything that can be done
to drive more chemical protection to the brain during the acute
pathological cascade will help reduce negative outcomes in the
concussed population,” stated Dr. James Kelly, Chief Medical
Officer at Oragenics.
Concussion is a serious unmet medical need.
There are an estimated 69 million concussions annually reported
worldwide. Common causes of concussion include falls, motor vehicle
accidents, military incidents, 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 Oragenics 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
intranasal formulations and intranasal devices for delivering the
intranasal formulations. For more information, please visit
www.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
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
Officer813-286-7900jhuffman@oragenics.com
Investor Relations:Rich CockrellCG
Capital404-736-3838ogen@cg.capital
Oragenics (AMEX:OGEN)
Historical Stock Chart
From Jul 2024 to Aug 2024
Oragenics (AMEX:OGEN)
Historical Stock Chart
From Aug 2023 to Aug 2024