ENGLEWOOD, Colo., April 27, 2021 /PRNewswire/ -- Ampio
Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company
focused on the advancement of immunology-based therapies for
prevalent inflammatory conditions, today announced that it had
received a positive response from the U.S. Food and Drug
Administration (FDA) on its plans for its AP-013 Phase III trial
for the intra-articular injection of Ampion™, its novel
anti-inflammatory, for patients suffering from severe
osteoarthritis of the knee (OAK).
"I am pleased with the positive response we received from the
FDA on our AP-013 study," commented Michael
Macaluso, President and CEO of Ampio. "The FDA's response
provides guidance and flexibility on how to maintain the Special
Protocol Assessment, or SPA, while allowing the company to evaluate
and consider several paths for moving the program forward. We will
be further evaluating the FDA's guidance internally and, in
addition, discuss the options with potential partners. We will
provide additional details on our upcoming earnings call on
May 5th."
The AP-013 study was paused in early 2020, along with over 1,000
other trials, because of the COVID-19 pandemic, and the FDA was
providing Ampio with guidance on steps for moving forward and
completing the trial. The AP-013 study is being conducted under a
Special Protocol Assessment (SPA) which provides a documented and
structured framework for communication and gaining agreement with
the FDA to support a commercial Biologics Licensing Application
(BLA).
As previously noted, Ampio will provide an update on its plans
for this trial at its upcoming earnings call on May 5th.
The company also reported that all patients in its AP-014 Phase
I trial of inhaled Ampion for COVID-19 acute respiratory distress
syndrome (ARDS) had completed treatment, including a follow-up at
Day 28 after treatment. The study not only met its primary endpoint
of safety and tolerability, but the final data showed an even
greater improvement in all-cause mortality over patients treated
using Standard of Care (SOC) than reported at the time of the
interim analysis. Specifically, mortality in the SOC group was 24%
(interim analysis reported as 21%), while in the group treated with
Ampion mortality was only 5% (interim analysis reported as 8%).
(See separate release for more details.)
"These are strong results from a Phase I trial, and we are
looking forward to continuing immediately with a set of
double-blind placebo-controlled Phase II trials utilizing Ampion in
patients adversely impacted by COVID-19, both in an inhaled form
for lung inflammation and intravenously for more systemic symptoms
of COVID-19," continued Macaluso. "We have IRB approvals for both
trials will commence enrolling patients in the U.S."
Separately, the Phase I study using Ampion to address the
respiratory symptoms experienced by COVID-19 "Long Haulers" is
awaiting Investigational Review Board (IRB) approval and is
expected to commence enrollment shortly. A significant percentage
of the millions of people who have contracted COVID-19 over the
past year – even those with mild or asymptomatic cases – continue
to suffer the debilitating effects from the disease long after
there is no detectable virus in their system. These "long hauler"
COVID-19 symptoms are now known clinically as Post-Acute Sequelae
of SARS-CoV-2, or PASC.
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.
Company Contacts
Investor Relations
Joe
Hassett
joeh@gregoryfca.com
484-686-6600
Media Contact
Katie
Kennedy
katie@gregoryfca.com
610-731-1045
View original content to download
multimedia:http://www.prnewswire.com/news-releases/ampio-pharmaceuticals-provides-updates-on-clinical-programs-for-ampion-in-osteoarthritis-and-covid-19-301277982.html
SOURCE Ampio Pharmaceuticals, Inc.