ENGLEWOOD, Colo., July 23, 2020 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE American: AMPE) (the "Company" or
"Ampio"), is a biopharmaceutical company focused on the
development and advancement of immunology-based therapies for
prevalent inflammatory conditions. As part of this program, the
Company is actively working on the development of therapies for
patients infected with the SARS-CoV-2 virus ("COVID-19").
Patients are being dosed in a Phase 1 United States based
clinical trial evaluating a 5-day intravenous ("IV")
AmpionTM treatment for COVID-19 patients requiring
supplemental oxygen. The primary endpoint for this randomized,
controlled study will evaluate the safety and tolerability of
IV Ampion treatment in adult
COVID-19 patients requiring oxygen supplementation. Additional
details of the trial can be found on
ClinicalTrials.gov (NCT04456452).
Ampion is an immunomodulatory anti-inflammatory agent that has
been shown to inhibit the expression of proinflammatory cytokines,
including tumor necrosis factor alpha (TNFα), by repressing their
transcription. Proinflammatory cytokines like TNFα are believed to
play a key role in the overactive inflammatory response, or
cytokine storm, in the lungs of COVID-19 patients who require
supplemental oxygen. Ampion may be effective in interrupting the
inflammatory cascade associated with COVID-19 and improve the
clinical course and outcome of patients. A manuscript detailing
this mechanism of action titled, "The novel immunomodulatory
biologic LMWF5A (Ampion) for pharmacological attenuation of the
"cytokine storm" in COVID-19 patients: a hypothesis", has been
published in a peer-reviewed journal
( 10.1186/s13037-020-00248-4).
"Our understanding of COVID-19 continues to evolve, and we are
pleased to partner with Ampio in this trial to assess Ampion's
potential as a treatment in the fight against COVID-19. It is clear
that modulation of the immune response to COVID-19 is one of the
most promising therapeutic targets. We are very interested in
investigating Ampion's effect on inflammation in this setting,"
said trial Principal Investigator Dr. Michael Roshon, MD, PhD,
Chief of Staff at Penrose-St. Francis
Hospital in Colorado Springs, Colorado.
About Ampio Pharmaceutical
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," "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 Contact
Dan Stokely, CFO
Phone: (720) 437-6500
info@ampiopharma.com
Ampio Pharmaceuticals, Inc.
AMPE
View original content to download
multimedia:http://www.prnewswire.com/news-releases/ampio-starts-patient-enrollment-in-its-ampion-covid-19-program-301098462.html
SOURCE Ampio Pharmaceuticals, Inc.