ENGLEWOOD, Colo., July 29, 2021 /PRNewswire/ -- Ampio
Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical
company focused on the advancement of immunology-based therapies
for prevalent inflammatory conditions, today announced details on
the Company's poster presentation, "Efficient Applied Toxicology
during COVID-19: A Preclinical Study that Advanced Clinical Use of
Ampion," being given virtually at the American College of
Toxicology 42nd Annual Meeting, November 14
to 17, 2021, at the Gaylord National Harbor in Washington, DC.
Ampio's poster is based on the Company's preparations for its
recently completed AP-014 Phase I clinical trial utilizing an
inhaled form of Ampio's drug, Ampion™, for treatment of respiratory
distress in patients as a result of COVID-19. The study showed
inhaled Ampion significantly reduced all-cause mortality for
patients suffering from COVID-19 induced respiratory distress by
78% over the Standard of Care (SOC) alone. Based on those strong
positive results, Ampio has recently undertaken a Phase II
trial.
Prior to launching the initial AP-014 trial, Ampio undertook
pre-clinical research to establish the safety of its Ampion
anti-inflammatory therapy whereby the method of use would be
through inhaled delivery. Ampion, a novel biologic drug containing
a blood-derived cyclized peptide and other small molecules, with
the potential for treating a variety of serious and often
life-threatening inflammatory conditions, had previously
demonstrated its safety utilizing injection and intravenous (IV)
delivery formats in other previously completed trials.
The FDA identified a need to assess the
no-observed-adverse-effect level (NOAEL) in animals with Ampion via
inhalation as the intended route of administration. Ampio designed
a study with FDA feedback to assess the potential local toxicity to
the lung and other respiratory tissues at a range of inhalation
doses. The company's presentation will highlight the program as an
example of efficient development that is responsive to both the
COVID-19 pandemic and FDA requirements.
The presentation will be given by Laura
Goldberg and Holli Cherevka,
both of Ampio Pharmaceuticals based in Englewood, CO, and Philip J. Kuehl of Lovelace Biomedical based in
Albuquerque, NM.
For more information on the abstract presentation or American
College of Toxicology 42nd Annual Meeting, visit
https://www.actox.org/am/am2021/.
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 using words such as
"believe," "expect," "plan," "anticipate," and similar expressions.
These forward-looking statements include statements regarding
Ampio's expectations with respect to Ampion and its classification,
as well as those associated with regulatory approvals and other FDA
decisions, the Biological License Application (BLA), the ability of
Ampio to enter into partnering arrangements, clinical
trials and decisions and changes in business conditions and similar
events, the ability to receive regulatory approval to conduct
clinical trials, that Ampion may be used to treat ARDS induced by
COVID-19, all of which are inherently subject to various risks and
uncertainties. 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, under
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
katiek@gregoryfca.com
610-731-1045
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SOURCE Ampio Pharmaceuticals, Inc.