Oragenics, Inc. Prepares Intranasal Pharmaceutical, ONP-002, for Phase II Concussion Trial
May 16 2024 - 8:00AM
Oragenics, Inc. (NYSE American: OGEN), a pioneering pharmaceutical
company specializing in intranasal treatments for neurological
disorders, today announced an update on the company and its drug
development program. Oragenics is designing an upcoming Phase II
clinical trial conducted in acute and emergency departments. The
company is preparing to initiate a Phase II clinical trial for its
lead drug candidate, ONP-002, an innovative neurosteroid designed
to treat mild Traumatic Brain Injury (mTBI), commonly referred to
as concussion.
Advancements in Drug Formulation for Phase II
TrialOragenics is focused on enhancing the formulation of
ONP-002 by increasing the percentage of active compound in the
final spray-dried intranasal powder. The formulation improvements
aim to optimize the size of the emitted particles, ensuring they
are large enough to prevent deep lung inhalation while maximizing
intranasal absorption and brain targeting. This intranasal delivery
method is crucial for bypassing the blood-brain barrier,
facilitating rapid and efficient drug delivery to the brain within
minutes.
Clinical Trial PreparationsIn preparation for
the Phase II clinical trial, Oragenics has secured an adequate
supply of intranasal devices. The company has also partnered with
Avance Clinical Pty Ltd, a renowned Clinical Research Organization
(CRO) based in Adelaide, Australia. This collaboration will
facilitate the implementation of the Phase IIa trial in emergency
departments at level one trauma centers, which Oragenics
anticipates will result in a robust and well-structured study.
Leadership Insights“We are privileged to
collaborate with exceptional GMP pre-clinical research teams
dedicated to optimizing our drug formulation and intranasal device
components,” stated Michael Redmond, President of Oragenics. "Our
continued partnership with Avance Clinical has been instrumental in
ensuring a seamless transition into our Phase II clinical
trial.”
Preclinical studies have demonstrated that ONP-002 significantly
improves molecular and behavioral outcomes following brain injury.
Additionally, intranasal delivery of ONP-002 as a nanoparticle has
shown enhanced brain exposure and metabolism, underlining the
potential of this innovative treatment.
Dr. James Kelly, Chief Medical Officer of Oragenics, added, “Our
Phase I human study has confirmed that ONP-002 is well tolerated in
humans. We are encouraged by the progress and support we have
received in optimizing our program, setting the stage for the
launch of our Phase II trials.”
Addressing an Unmet Medical NeedConcussion
remains an unmet medical need, with an estimated 69 million cases
reported globally each year. Common causes include falls, motor
vehicle accidents, and contact sports. Concussions are also
associated with long-term neurological disorders such as
Alzheimer's Disease, Parkinson's Disease, and Chronic Traumatic
Encephalopathy (CTE). Post-concussion syndrome, which can lead to
long-term disability, affects up to 20% of patients with
concussion.
Oragenics remains committed to advancing its groundbreaking
intranasal pharmaceutical solutions, aiming to provide effective
treatments for neurological disorders and to improve patient
outcomes worldwide.
About Oragenics, Inc.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 powder
formulation and an intranasal delivery device. 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 trials 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
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