Oragenics Inc. Successfully Completes Key FDA-Recognized Study for ONP-002
08 Octobre 2024 - 2:45PM
Oragenics Inc. (NYSE American: OGEN), a company focused on
developing new treatments for brain-related health conditions, has
completed a key study for their new concussion drug, ONP-002. This
drug is designed to be delivered through the nose, which could help
it reach the brain quickly after a head injury.
The recent study shows that the drug successfully targets areas
inside the nose that are connected to the brain. This makes it more
likely to reach and treat the brain after a concussion. Intranasal
casting studies are valued by the FDA for pharmaceuticals delivered
via the nasal passage and accept such studies in FDA submissions.
Oragenics is now preparing to move forward with human testing
(Phase II) in patients who come to the emergency room with a
concussion, aiming to give the first dose of the drug within 8
hours of the injury.
"In preparing for our Phase II study, we wanted to study whether
our nasal spray device would give ONP-002 an increased chance of
reaching the brain quickly after a concussion. The study results
are promising, as they show the drug targets areas in the nose
directly linked to the brain. This should increase the chances of
the drug being effective in treating concussion and reduces the
likelihood of it being swallowed, which is another encouraging
sign," said Michael Redmond, President of Oragenics.
In this study, ONP-002 was tested using a special nasal spray
device. The goal of intranasal casting studies is to identify where
the drug lands inside an anatomical model of the interior nose that
is made from cast metal (AINI). The model is standard for
intranasal drug delivery and is accepted by the FDA as a surrogate
for the actual nasal passage. The results were promising, showing
that the drug spreads well in the areas of the nose where it can be
quickly absorbed into the brain. This makes it a strong candidate
for potentially helping people recover from concussions.
Concussions are a common problem, with around 69 million people
affected every year. Many concussions happen due to falls, car
accidents, or sports injuries, and long-term symptoms can develop
in up to 20% of patients. Currently, there is no pharmaceutical
treatment for concussions, which is why Oragenics' work is so
important.
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 powder formulation and an intranasal delivery
device. For more information, please
visit www.oragenics.com.
About Nasal CastingThe FDA values studies on
nasal drug delivery systems and accepts them in submissions for
pharmaceuticals that use the nasal passage. These studies are
critical for assessing the bioavailability and bioequivalence of
drugs, particularly nasal aerosols and sprays. The FDA's guidance
on bioavailability and bioequivalence emphasizes the use of in
vitro and in silico methods (like computational simulations) to
assess how drugs are deposited and distributed within the nasal
cavity. These methods help ensure that both new drug applications
(NDAs) and abbreviated new drug applications (ANDAs) meet
regulatory requirements.
Reference Links:
- Bioavailability and
Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for
Local Action.
- Computational Simulations
Shed Light on Factors Affecting Nasal Spray
Distribution.
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Investor Relations:Rich Cockrell404.736.3838achv@cg.capital
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