ENGLEWOOD, Colo., June 25, 2021 /PRNewswire/ -- Ampio
Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical
company focused on the advancement of immunology-based therapies
for prevalent inflammatory conditions, today announced
randomization and dosing of patients in its multi-center AP-019
Phase II clinical trial, using inhaled Ampion™ in the treatment of
respiratory distress due to COVID-19, is underway.
"We saw strong, positive results in our Phase I trial, reducing
all-cause mortality in COVID-19 respiratory distress by 78%. If
this Phase II study further confirms the efficacy results seen in
our Phase I study, I can envision moving forward quickly with
an application for Emergency Use Authorization for Ampion in
treating patients suffering from respiratory distress due to
COVID-19," said Michael Macaluso,
President and CEO of Ampio.
As an immunomodulatory agent with anti-inflammatory effects,
Ampion interrupts the hyperactive immune response associated with
COVID-19 and may improve the clinical outcome for patients
suffering from its complications.
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 patients
suffering from COVID-19 respiratory distress by 78% over the
Standard of Care (SOC). Specifically, mortality in the SOC group
was 24%, while in the group treated with Ampion, mortality was only
5%.
"Roughly 300 people per day are dying of COVID-19 in the U.S.,"
Macaluso continued, "with a seven-day average of 10,000 per day
worldwide. There is a perception the vaccine rollout has ended the
pandemic, but COVID-19 is likely to remain a concern for some time
to come, and physicians need tools to treat it."
Ampio also recently received approval from the FDA to expand the
AP-019 study to India, which has
recently seen a dramatic surge in COVID-19 cases.
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 2037 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.