ENGLEWOOD, Colo., June 17,
2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE
American: AMPE), a biopharmaceutical company focused on the
advancement of immunology-based therapies for prevalent
inflammatory conditions, today reported newly integrated data from
four of its earlier clinical trials with consistent inclusion,
exclusion, and demographic populations utilizing Ampion for
treating osteoarthritis of the knee (OAK). Data from these 585
patients categorized as severe (i.e., Kellgren-Lawrence grade 4, or
KL 4) demonstrates Ampion's consistent and statistically
significant clinical effect in the reduction of pain compared to
saline at two, ten, and twelve-week intervals subsequent to
intra-articular injection.
"These 585 KL 4 patients in our earlier trials represent the
largest available and reported dataset of severe OAK patients to
date, and the data analysis clearly show Ampion as the first
therapy to demonstrate clinical efficacy in patients suffering from
severe OAK," said Michael Macaluso,
President and CEO of Ampio. "Severe OAK remains a critical unmet
medical need. We have already secured one pivotal trial that the
FDA has agreed we can use to file our Biologics License Application
(BLA), and, while our latest Phase III AP-013 clinical trial in OAK
had to be paused because of the COVID-19 pandemic, the high degree
of efficacy seen in the integrated data for KL 4 patients from the
previous four trials gives us confidence to expect a positive
outcome when it comes time to unblind this study."
Top-line results from Ampio's AP-003-A, AP-003-B, and AP-004
trials were previously published in Orthopedics (Orthopedics.
2018; 41(1):e77-e83), which reflected a clinically and
statistically significant reduction in pain at weeks ten and twelve
following a single injection, compared to saline, using the
Western Ontario and McMaster
Universities Osteoarthritis Index (WOMAC) scale. In addition,
Ampion showed a 35.6% and 33.2% reduction in pain at weeks ten and
twelve compared to baseline, while saline showed a reduction of 29%
and 24.7%, with a p value of 0.04 and 0.012 comparing the two,
respectively.
Today's announcement integrates data from severe OAK patients
who were enrolled in Ampio's AP-003-C Phase III clinical trial with
the previously published results. The pooled data show an even
greater statistical significance, with a reduction in pain of 34.3%
at two weeks (compared to 28.6% for saline, p value 0.041), 38.1%
at ten weeks (30.4% for saline, p value 0.006) and 36% at twelve
weeks (25.7% for saline, p value <0.001). See Figure 1.
Ampion has proven safe in thousands of enrolled and randomized
patients, supporting repeat administration. No drug-related serious
adverse events (SAEs) or treatment-related deaths have occurred,
and the majority of adverse events (AEs) were unrelated to
treatment. The incidence and severity of adverse events are similar
for Ampion and saline, and the incidence of related AEs is far
lower than that reported for existing therapies.
"Ampion is on track to become the first novel drug with unique
mechanisms of action on the market for OAK in over 20 years. Ampion
treatment has demonstrated consistent clinical efficacy in patients
suffering from OAK across multiple trials, periods of time and
clinical sites. In addition, the FDA has provided written
confirmation that the AP-003-A study provides evidence of the
effectiveness of Ampion" continued Macaluso. "We continue to remain
confident the data from the suspended Phase III AP-013 trial will
show similar safety and efficacy, but the decision whether to
unblind this double masked, randomized controlled study or to
continue adding patients ideally should be jointly decided with
future potential partners."
About Osteoarthritis of the Knee (OAK)
According to a recent estimate published in The Lancet,
around 650 million people worldwide suffer from osteoarthritis of
the knee (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 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.