ENGLEWOOD, Colo., Aug. 13, 2021 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical
company focused on the advancement of immunology-based therapies
for prevalent inflammatory conditions for which there are limited
treatment options, today announced a preprint version of a
manuscript, "LMWF5A Demonstrates an Anti-Inflammatory Mode of
Action and Similar Drug Targets to Dexamethasone in Activated
PBMC," has been posted on In Review, a preprint platform
hosted on Research Square.
The paper highlights important preclinical research done on the
mode of action of Ampion™, Ampio's novel anti-inflammatory biologic
therapy, showing that Ampion may be used to treat conditions that
are supported for dexamethasone but with fewer or less harmful side
effects.
"It is imperative that new research on possible treatments be
shared as quickly as possible," said David Bar-Or, M.D., Director
and Founder of Ampio Pharmaceuticals and a co-author of the paper.
"This research demonstrates an opportunity to provide
anti-inflammatory benefit with limited side effects with Ampion
treatment. Making this paper available in preprint format on In
Review makes research communication faster, fairer, and
potentially more useful in the fight against COVID-19."
Ampio Pharmaceuticals is currently conducting two Phase II
clinical trials for use of Ampion in treating COVID-19, in an
inhaled format for COVID-19 related respiratory distress and
intravenously (IV) for systemic complications. Additional trials
are underway for "long-haul" COVID-19 and osteoarthritis of the
knee (OAK).
The preprint paper stems from an unbiased investigation of
Ampion's effects on activated immune cells in various conditions.
Differential gene expression analysis determined transcriptional
changes due to Ampion treatment, and Ingenuity Pathway Analysis
software identified compounds with comparable or contrasting
activities to Ampion. Analysis revealed broad anti-inflammatory and
pro-resolving activities for Ampion, with predicted inhibition of
key pro-inflammatory mediators and functions as well as activation
of some anti-inflammatory mediators.
Upstream regulator analysis identified dexamethasone as the most
significantly similar drug. Further comparison of Ampion and
dexamethasone revealed similar, but not identical, targets and
directional regulation. This study supports the current knowledge
on the mode of action of Ampion and provides new hypotheses for
future investigations. Due to its analogous biological effects
compared to dexamethasone and its known safety profile, Ampion may
be used to treat conditions that are supported for dexamethasone
with fewer or less harmful side effects.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals,
Inc. is a biopharmaceutical company primarily focused on the
advancement of immunology-based therapies to treat prevalent
inflammatory conditions for which there are limited treatment
options. Ampio's lead drug, Ampion™, is backed by an extensive
patent portfolio with intellectual property protection extending
through 2037 and will be eligible for 12-year FDA market
exclusivity upon approval as a novel biologic under the Biologics
Price Competition and Innovation Act (BPCIA).
Forward Looking Statements
Ampio's statements in this
press release that are not historical fact, and that relate to
future plans or events, are forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements can be identified by the use of words
such as "could," "believe," "expect," "plan," "anticipate," and
similar expressions. These forward-looking statements include
statements regarding Ampio's ability to access equity financing and
fund research and development programs and operations through the
fourth quarter of 2022, expectations with respect to Ampion,
including its ability to treat prevalent inflammatory conditions
for which there are limited treatment options (including COVID-19)
and its ability to offer the benefits of steroids without the side
effects, the significance of reported results in early clinical
trials, the timing of patient enrollment for the Phase I Long-COVID
trial and the Phase II COVID-19 trials, the timing and outcome of
the Company's application for Emergency Use Authorization of Ampion
in COVID-19 patients with inhalation and intravenous routes of drug
delivery, the term of Ampion's patent protection and the timing and
likelihood of Ampion's approval as a novel biologic under the
BPCIA, including the availability of 12-year FDA market exclusivity
in connection with such approval. These forward-looking statements
are made on the basis of the current beliefs, expectations, and
assumptions of the management of Ampio and are subject to
significant risks and uncertainties that could cause actual results
to differ materially from what may be expressed or implied in these
forward-looking statements. The risks and uncertainties involved
include those detailed from time to time in Ampio's filings with
the Securities and Exchange Commission, including without
limitation, in Ampio's Annual Report on Form 10-K and other
documents filed with the Securities and Exchange Commission. Ampio
undertakes no obligation to revise or update these forward-looking
statements, whether as a result of new information, future events
or otherwise.
Media Contact
Katie
Kennedy
katie@gregoryfca.com
610-731-1045
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SOURCE Ampio Pharmaceuticals, Inc.