ENGLEWOOD, Colo., Dec. 14, 2017 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) today reported that the
Phase 3 clinical trial of Ampion™ met its primary endpoint with 71%
of Ampion™ treated patients meeting the OMERACT-OARSI responder
criteria, which exceeds the physician reported threshold of 30% for
a meaningful treatment in severe osteoarthritis of the knee (p <
0.001). Responders experienced, on average a 53% decrease in pain
as measured by WOMAC A and a 50% improvement in function as
measured by WOMAC C and a 45% improvement in quality of life as
measured by Patient Global Assessment (PGA). In the secondary
endpoints, Ampion™ treated patients achieved statistical
significance in a composite endpoint of pain and function from
baseline in both categories at 12 weeks (p < 0.001), which was
supported by an increase in quality of life as measured by patient
global assessment (PGA) (p < 0.001). When treated with Ampion™
(n=144), patients experienced significant improvement in a
composite endpoint of pain and function compared to all KL 4
saline-treated patients (n=206) in Ampion™ phase 3 clinical trials
(p < 0.001).
If approved, Ampion™ would be the first intra-articular
injection to treat the signs and symptoms of patients with severe
osteoarthritis of the knee (Kellgren-Lawrence x-ray grade 4).
In order to support a label for signs and symptoms, Ampion™ was
asked to demonstrate clinical efficacy in a composite response of
pain, function and be supported by quality of life.
Ampion™ was well tolerated with treatment-emergent adverse
events (TEAEs) comparable to those of placebo in all
single-injection studies of Ampion™. There were no drug-related
serious TEAEs associated with the Ampion™ arm. The safety and
tolerability profile of Ampion™ is consistent with previous
studies. To date, Ampion™ has been given to over 900 patients
with no reported drug-related serious TEAEs.
Ampio plans to present a more detailed analysis of the Phase 3
and pooled data at an upcoming scientific meeting as well as
submission for publication.
"We are very pleased with the positive Phase 3 data as we
believe that Ampion™ will address an unmet medical need, providing
severely diseased patients a non-opioid option that not only
reduces pain, but also improves function and quality of life in a
meaningful way" said Michael
Macaluso, Chairman and CEO, Ampio Pharmaceuticals. "We are
hopeful that Ampion™ will serve as a safe and effective treatment
for an incurable, progressive disease that afflicts 21 million
people in the U.S. and over 200 million people worldwide who suffer
from osteoarthritis. We look forward to working closely with the
U.S. Food and Drug Administration (FDA) as we prepare to submit our
Biologics License Application (BLA) for Ampion™."
In this multi-center, randomized study of 144 KL4 patients with
severe OAK of the knee, patients received either a single 4mL
intra-articular injection of Ampion™ or placebo at a ratio of 6:1.
The primary endpoint of responder analysis using OMERACT-OARSI was
evaluated at 12-weeks following a single injection.
The OMERACT-OARSI response composite looks to assess three core
symptoms of OAK (pain, function, and patient's global assessment)
as a single variable. For each domain, a response requires both a
relative and an absolute change. OMERACT-OARSI response is defined
as having a high improvement in pain or function and/or a
clinically meaningful improvement in two of three core measurements
of OA: pain, function or quality of life. Specifically, to be
considered a responder, a patient must demonstrate improvement in
WOMAC A (pain) or WOMAC C (function) of ≥50% and absolute change of
≥1.0 point on a 5 point Likert (0-4) scale, or ≥20% improvement in
at least 2 of the following 3 categories: WOMAC A, WOMAC C,
or Patient Global Assessment, with a 0.5 point change on a 5
point (0-4) pain scale.
Conference Call
At 8:30
a.m. ET tomorrow, Ampio's management will host a conference
call to discuss the Phase 3 clinical results. The dial-in
number for the conference call is (877) 260-1479 for
U.S./Canada participants and (334)
323-0522 for local participants, with Participant Passcode #
6638480. A live webcast of the conference call can also be accessed
through the "Investors" tab on the Ampio Pharmaceuticals website
at www.ampiopharma.com. A webcast replay will be available
online after the call.
About Osteoarthritis
Osteoarthritis (OA) is an
incurable and progressive disorder of the joints involving
degradation of the intra-articular cartilage, joint lining,
ligaments, and bone. The incidence of developing osteoarthritis of
the knee over a lifetime is approximately 45%. As this disease is
associated with age, obesity, and diabetes, this number will
continue to grow. Certain risk factors in conjunction with natural
wear and tear lead to the breakdown of cartilage. Osteoarthritis is
caused by inflammation of the soft tissue and bony structures of
the joint, which worsens over time and leads to progressive
thinning of articular cartilage. Other symptoms include narrowing
of the joint space, synovial membrane thickening, osteophyte
formation and increased density of subchondral bone.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals,
Inc. is a development stage biopharmaceutical company primarily
focused on the development of therapies to treat prevalent
inflammatory conditions for which there are limited treatment
options. We are developing compounds that decrease inflammation by
(i) inhibiting specific pro-inflammatory compounds by affecting
specific pathways at the protein expression and the transcription
level; (ii) activating specific phosphatase or depletion of the
available phosphate needed for the inflammation process; and (iii)
decreasing vascular permeability.
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 clinical trials of our Ampion™ product. 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 Quarterly Reports on Form 10-Q. Ampio undertakes no
obligation to revise or update these forward-looking statements,
whether as a result of new information, future events or
otherwise.
Company Contact
Tom
Chilcott
Chief Financial Officer
Phone: (720) 437-6500
tchilcott@ampiopharma.com
Media Contact
Chiara
Russo
Director, Investor Relations
Lavoie Health Science
Phone: (617) 374-8800 ext. 112
crusso@lavoiehealthscience.com
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SOURCE Ampio Pharmaceuticals, Inc.