ENGLEWOOD, Colo., Sept. 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 top-line results
from AP-013, a randomized, saline-controlled, double-blind Phase
III clinical study evaluating the efficacy of an intra-articular
(IA) injection of Ampion™ in adults with pain due to severe
osteoarthritis of the knee (OAK). In the study, Ampion
demonstrated a statistically significant reduction in pain and
improvement in function at 12 weeks in severe OAK patients.
The AP-013 study was designed to confirm the efficacy of an IA
injection of Ampion for the treatment of patients with
severe OAK and the second of the two required Phase III pivotal
trials. The FDA has acknowledged that Ampion has
demonstrated efficacy in OAK patients after accepting AP-003-A as
the first of two required Phase III pivotal studies. The FDA
has identified severe OAK as an unmet medical need, and there are
currently no FDA-approved drugs for the indication of pain from
severe OAK, for which Ampion is indicated.
As a result of the COVID-19 pandemic, the FDA recommended that
the Company identify subject information that was impacted by the
pandemic during the AP-013 clinical study and conduct a sensitivity
analysis to detect potential biases related to the pandemic. The
Company has followed FDA's guidance, completed a top-line analysis,
and performed the FDA-recommended sensitivity analysis. The
resulting data demonstrates a statistically significant impact from
the pandemic (p<0.001). In addition, a separate statistical
analysis of data from the 725 patients that the Company believed
not to have been impacted by the pandemic demonstrated a
statistically significant reduction in pain (p=0.0260) and
improvement in function (p=0.0073), versus a critical p-value of
0.05, at 12 weeks with Ampion treatment compared to saline
control. We plan to thoroughly analyze and consolidate all
this study data with data from severe OAK patients in previous
single-injection clinical studies performed by the Company and
present it to the FDA in support of a BLA.
The study used the WOMAC ® A (Pain Subscale) index / scoring
system as the measurement of pain and WOMAC ® C (Function Subscale)
index / scoring system as the measurement of function and the
statistical analysis for computing the top-line results utilized
the same methodology defined in the first pivotal study (AP-003-A).
These results obtained are consistent with the results from severe
OAK patients in prior OAK trials conducted by the Company and
significantly expand the set of severe OAK patients treated with
Ampion. The safety profile of Ampion remains
strong, and no treatment-related serious adverse events were
observed among the cohort of patients who received
Ampion.
"We are deeply grateful to the patients, investigators and
others who have participated in this study," shared Mike Macaluso, President & CEO of Ampio. "I
am also very pleased with our current cash and liquidity runway,
which we believe is sufficient to support our basic operations and
expected incremental spend for current and ongoing clinical trials
for approximately twelve months, while we continue regulatory and
partnering discussions related to Ampion. We will complete
the analysis of the AP-013 study and present all data to the FDA
with the goal of filing a BLA for Ampion."
About Osteoarthritis of the Knee
According to a recent estimate published in The Lancet, around
650 million people worldwide suffer from OAK, an inflammatory,
progressive, incurable disease characterized by elevated cytokines.
Beyond being a mere quality of life issue, people who suffer from
osteoarthritis have a significantly higher mortality rate than the
general population.
Elevated levels of the cytokines TNFα and IL-12 are associated
with pain and loss of function, while IL-1β and IL-6 are associated
with disease severity. Ampion is the only therapy with
demonstrated efficacy in severe OAK. Ampion's mechanism of
action targets multiple pathways responsible for elevated cytokines
to provide a therapeutic effect. Multiple human in vitro
models have demonstrated the anti-inflammatory action of
Ampion, reducing CXCL10 by up to 69%, IL-6 by up to 74%,
IL-12 by up to 66% and TNFα by up to 55%.
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 is expected to be eligible
for 12-year FDA market exclusivity upon approval as a novel
biologic under the Biologics Price Competition and Innovation Act
(BPCIA). Ampio operates its own modern, state-of-the-art
manufacturing and testing facility built to support clinical
supply, product/process development, and long-term commercial
production of Ampion. The facility was designed to meet
international regulatory compliance standards and has the capacity
to support global demand.
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 using 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,
the significance of the top-line results from the AP-013 study, the
FDA's acceptance of the Company's analysis and or interpretation of
the results, Ampio's cash runway and ability to sustain operations
for twelve months, the strength and enforceability of Ampio's
patent portfolio and its eligibility for FDA market exclusivity,
the ability of Ampio to enter into partnering arrangements, the
timing and likelihood of success of a BLA for Ampion and other
statements that are not purely statements of historical fact. These
forward-looking statements are made on the basis of the current
beliefs, expectations, and assumptions of Ampio's management and
are subject to significant risks and uncertainties that could cause
actual results to differ materially from what may be expressed or
implied in these forward-looking statements. 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. In addition, as stated in the Company's filings with
the Securities and Exchange Commission, the FDA may determine that
the COVID-19 pandemic may have impacted its ability to interpret
the Company's study results and may or may not require additional
studies in support of an Ampion BLA. 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
katiek@gregoryfca.com
610-731-1045
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SOURCE Ampio Pharmaceuticals, Inc.