ENGLEWOOD, Colo., Feb. 23, 2021 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE American: AMPE), a
biopharmaceutical company focused on the advancement of
immunology-based therapies for prevalent inflammatory conditions,
today announced the addition of two new study sites to further the
expansion of its ongoing U.S. Phase I clinical trial for inhalation
treatment of COVID-19 with Ampion ("AP-014"). Principal
Investigator Luciano Lemos-Filho,
M.D., in Pulmonary and Critical Care and Medical Center Intensive
Care Unit Director at Swedish Hospital in Denver, CO, and Principal Investigator
David King, M.D., Medical Director
at Bozeman Health Clinical Research in Bozeman, MT, bring additional experience to
the study and will accelerate the enrollment of patients in the
trial.
"Patients suffering from life-threatening lung inflammation due
to COVID-19 have a desperate need for treatments," said Dr.
David King of Bozeman Health
Clinical Research. "Ampion's anti-inflammatory effects and its
method of action suggest it may offer relief to our patients. We
are pleased to be able to work with Ampio Pharmaceuticals in this
early-stage trial of Ampion in treating COVID-19 related
respiratory distress."
"Expanding the trial to include these doctors and their clinical
sites will enhance our speed and ability to enroll patients and
gather the data needed to prove the safety and potential
efficacy of Ampion in treating COVID-19," commented Mike Macaluso, CEO of Ampio Pharmaceuticals.
"The trial involves only five days of treatment with Ampion
delivered through inhalation, which our research suggests should be
sufficient to show clinical effect over the Standard of Care for
lung inflammation in COVID-19. Preliminary data from the study
shows that Ampion has improved all-cause mortality."
Nearly 28 million people in the United
States have been diagnosed with COVID-19, a full quarter of
the cases worldwide. Despite the growing availability of vaccines,
therapeutics are, and will continue to be, necessary to treat
patients suffering from some of the virus' most challenging and
damaging effects, such as systemic inflammation in the lungs.
In this trial, Ampion is administered to patients by inhalation,
allowing the drug to directly target and attenuate inflammation in
the lungs. In addition, the trial will enroll 140 patients,
randomized 1 to 1, inhaled Ampion versus Standard of Care ("SOC"),
which can vary depending on patients' needs but includes any and
all of the best procedures and drugs approved by the US
Food and Drug Administration ("FDA") or under Emergency Use
Authorization through the FDA for use on patients with COVID-19.
Depending on disease severity, the SOC for COVID-19 may include
supportive care for complications, including supplemental oxygen
and advanced organ support, and therapies such as remdesivir or
dexamethasone. Safety is the primary end point of the AP-014 study,
with various measurements indicative of efficacy as secondary
endpoints. Inhalation is a new method for the administration of
Ampion which has been cleared for clinical use by the FDA. Recent
analysis of preliminary data showed that patients with COVID-19
respiratory complications and administered inhaled Ampion needed
less oxygen and showed greater clinical improvement than those
receiving the standard of care. Finally, inhaled Ampion also
improved all-cause mortality.
Ampio Pharmaceuticals continues to evaluate additional clinical
sites and expects to expand sites in the near term. Ampion is now
used in three active investigational new drug ("IND") programs –
inhalation, IV, and interarticular.
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 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.