ENGLEWOOD, Colo., May 21, 2021 /PRNewswire/ -- Ampio
Pharmaceuticals (NYSE American: AMPE), a clinical stage
biopharmaceutical company focused on the advancement of
immunology-based therapies for prevalent inflammatory conditions,
today announced details on the company's poster presentation,
"Regulatory Decisions during COVID-19: Efficient Nonclinical
Inhalation Toxicology for a Clinical Program," being given at the
23rd International Congress of the International Society for
Aerosols in Medicine (ISAM), in Boise,
Idaho, May 22 to 26, 2021.
The 23rd ISAM Congress is being held as a hybrid event. All
posters will be posted both on the website – along with an oral
presentation – and printed for display at the Boise Conference
Center. The poster itself can also be found here on the
"Publications" page on the Ampio Pharmaceuticals website.
In addition to its poster presentation, number 070, the company
has been invited to present at a workshop of the
Regulatory/Standardization issues networking group, which recently
published an appeal on the urgent need to accelerate the
development of inhaled therapies for COVID-19. The workshop,
entitled "Regulatory Guidance and Standards Required for the
detection, prevention of transmission, and development and approval
of inhaled vaccines and treatments for SARS -CoV-2 infections," is
scheduled on Saturday, May 22, 2021,
from 1:00 pm to 5:00 pm, and the
Ampio poster presentation takes place from 4:00 pm to 5:00 pm.
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™, in treating respiratory
distress in patients as a result of COVID-19. The study showed
inhaled Ampion reduced all-cause mortality in COVID-19 respiratory
distress by 78% over the Standard of Care (SOC) alone.
Prior to launching the trial, Ampio undertook pre-clinical
research to establish the safety of its Ampion anti-inflammatory
therapy in an inhaled format. 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.
For more details on the ISAM Congress and the timing of Ampio's
presentation, visit: www.isam.org.
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 2035 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 "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
katie@gregoryfca.com
610-731-1045
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SOURCE Ampio Pharmaceuticals, Inc.