ENGLEWOOD, Colo., March 29, 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 the company will present its findings on a poster
entitled, "Regulatory decisions during COVID-19: Efficient
nonclinical inhalation toxicology for a clinical program," at the
upcoming 23rd International Congress of the International Society
for Aerosols in Medicine (ISAM).
The ISAM Congress, which aspires to bring together over 400
attendees at one of the world's largest pulmonary drug delivery and
respiratory health conferences, will be held in Boise, Idaho, May 22 to
26, 2021 with an agenda focused on: Medical Aerosols in the
Age of COVID and other pandemics, acute and critical care, the
developing world, pulmonary disease, inhaled viruses and viral
transmission, health risks from environmental aerosols and emerging
aerosol technologies.
In addition to its poster presentation, number 070, the company
has been invited to present at 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. Presentation date and time has not yet been
determined.
In addition, Ampio recently completed enrollment in its AP-014
Phase I clinical trial utilizing inhaled Ampion in treating
respiratory distress in patients as a result of COVID-19. 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 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 23rd ISAM Congress is being held as a hybrid
event. All posters will be posted both on the website – along with
a short 2-to-5-minute oral presentation – and printed for display
at the Boise Conference Center. 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 clinical stage
biopharmaceutical company primarily focused on the development of
Ampion, our product candidate, 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.
Company Contacts
Investor Relations
Joe
Hassett
joeh@gregoryfca.com
484-686-6600
Media Contact
Katie
Kennedy
katie@gregoryfca.com
610-731-1045
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SOURCE Ampio Pharmaceuticals, Inc.