ENGLEWOOD, Colo., June 15, 2021 /PRNewswire/ -- Ampio
Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company
focused on the advancement of immunology-based therapies for
prevalent inflammatory conditions, today announced it has received
regulatory approval to expand enrollment of its AP-019 Phase II
study to India. The study will
utilize inhaled Ampion™ to treat those suffering from respiratory
distress due to COVID-19.
"FDA approval to include study sites in India further illustrates the continued need
for our therapy," said Michael
Macaluso, President and CEO of Ampio. "Currently,
India is reporting an average of
more than 3,200 daily deaths from COVID-19 and over 94,000 new
cases per day. We expect this expansion to shorten the timeline for
overall study enrollment and potentially assist one of the world's
highest density populations of COVID-19 infections."
The company initiated the AP-019, double-blind,
placebo-controlled Phase II trial, utilizing inhaled Ampion
following the strong top-line results achieved from its AP-014
Phase I trial. On April 27, 2021, the
company reported the earlier Phase I study not only met its primary
endpoint of safety and tolerability, but top-line results also
showed that Ampion reduced all-cause mortality in COVID-19
respiratory distress by 78% over the Standard of Care (SOC) for
COVID-19 respiratory distress. Specifically, mortality in the SOC
group was 24%, while in the group treated with Ampion, mortality
was only 5%.
Due to the ongoing political unrest in Israel and the surrounding region combined
with the reduction in COVID cases, the Company has a made a
strategic decision to discontinue the AP-019 study efforts in
Israel and reallocate and focus
these resources to select regions of India and other potential select territories
outside the United States,
depending on the ongoing magnitude of COVID-19 cases. More
information on the Company's COVID-19 trials can be found at:
https://ampiopharma.com/pipeline/ampion-and-inflammatory-lung-diseases-covid-19/
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company
primarily focused on the advancement of immunology-based therapies
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.
Media Contact
Katie
Kennedy
katie@gregoryfca.com
610-731-1045
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SOURCE Ampio Pharmaceuticals, Inc.