ENGLEWOOD, Colo., Feb. 1, 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 early
positive data from its ongoing U.S. Phase I controlled,
observer-blinded clinical trial of inhaled Ampion versus standard
of care for patients with COVID-19 respiratory distress
(AP-014).
An independent statistical analysis revealed patients
administered Ampion needed less oxygen and showed greater clinical
improvement than those receiving the standard of care for COVID-19
respiratory complications. Ampion improved all-cause mortality in
COVID-19 patients with respiratory distress compared to standard of
care, and there have been no drug-related serious adverse
events.
On this positive data, Ampio plans to increase the number of
patients in the trial from 40 to 140 and has added additional
hospitals as study sites. The new hospitals will accelerate the
pace of patient enrollment, and the additional data gained from the
added patients will help refine and accelerate future clinical
trials, as warranted.
More than 25 million people in the
United States have been diagnosed with COVID-19, nearly a
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.
In the trial, Ampion is administered to patients by inhalation,
allowing the drug to directly target and attenuate inflammation in
the lungs. This trial will now enroll 140 patients, randomized 1 to
1, inhaled Ampion versus standard of care, with each patient
inhaling 8 ml doses of Ampion four (4) times a day for five (5)
days. Safety is the primary end point, with various measurements
indicative of efficacy as secondary endpoints. Inhalation is a new
method for the administration of Ampion, cleared for clinical use
by the Federal Drug Administration (FDA). The Safety Monitoring
Committee (SMC), analyzing data from the trial, recently determined
there were no safety concerns related to inhaled Ampion in COVID-19
patients.
Preliminary analysis of data from the trial showed Ampion to be
an improvement over the standard of care. In fact, patients
receiving Ampion treatment required less oxygen, and were stable or
exhibited improvement on the Ordinal Scale and NEWS2 scale,
compared to the standard of care patients, respectively. The
Ordinal Scale was developed by the World Health Organization (WHO)
as a way to determine clinical improvement of COVID-19 patients.
The NEWS2 was similarly recommended by the National Institute for
Health and Care Excellence (NICE) in its guidelines for the
management of COVID-19 patients in critical care.
The analysis also showed Ampion improved all-cause mortality in
COVID-19 patients with respiratory distress compared to standard of
care patients.
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," "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
Investor Relations
Joe Hassett
joeh@gregoryfca.com
484-686-6600
Media Contact
Sarah May
sarahm@gregoryfca.com
215-205-1217
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SOURCE Ampio Pharmaceuticals, Inc.