ENGLEWOOD, Colo., June 19, 2020 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE American: AMPE) (the
"Company"), is a biopharmaceutical company focused on
the advancement of immunology-based therapies for prevalent
inflammatory conditions. As part of this program, the Company is
developing therapies for patients infected with the SARS-CoV-2
virus ("COVID-19").
The U.S. Food and Drug Administration ("FDA") completed its
review of the Company's Investigative New Drug ("IND") application
for intravenous ("IV") Ampion™ treatment for
COVID-19 affected patients and has cleared the company to proceed
with human trials.
The Company will begin a Phase 1 clinical trial to evaluate IV
Ampion as a treatment for COVID-19 patients on supplemental oxygen.
The need for supplemental oxygen in COVID-19 patients is indicative
of an inflammatory process in the lungs. As an immunomodulatory
anti-inflammatory agent, Ampion may be effective in interrupting
the inflammatory cascade associated with COVID-19 and improving the
clinical course and outcome of patients.
Years of extensive in-vitro studies on cell cultures have
confirmed that the mechanism of action ("MOA") of Ampion may be
suitable for the treatment of inflammatory conditions, such as
acute respiratory distress syndrome ("ARDS") and the cytokine
storm, associated with COVID-19. Many of these research related
findings have been published in peer reviewed, scientific journals,
which can be found on our website.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development 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 2032, 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," "may," "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, the timing
and outcome of clinical trials, and 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 Contact
Dan
Stokely, CFO
Phone: (720) 437-6500
info@ampiopharma.com
Ampio Pharmaceuticals, Inc.
AMPE
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SOURCE Ampio Pharmaceuticals, Inc.