Ampio Pharmaceuticals, Inc. Announces Positive Results for Ampion in
Osteoarthritis of the Knee Clinical Trial
Ampion Study Meets Primary Endpoint with High Statistical Significance; All
Primary Study Objectives were Achieved
GREENWOOD VILLAGE, Colo., Aug. 14, 2013
GREENWOOD VILLAGE, Colo., Aug. 14, 2013 /PRNewswire/ -- Ampio Pharmaceuticals,
Inc. (NYSE MKT: AMPE) today announced positive results from the SPRING study
(clinicaltrials.gov NCT01839331) of Ampion for the treatment of osteoarthritis
of the knee (OAK). In this study of 329 patients, patients treated with a
single intra-articular injection of Ampion achieved a clinically meaningful
reduction in pain.
The SPRING study, was a randomized (1:1:1:1), double-blind, vehicle controlled
trial designed to evaluate the safety and efficacy of Ampion in OAK patients.
Patients were randomized to receive one of two doses (4 mL or 10 mL) of Ampion
or corresponding saline control via intra-articular injection. The primary
study objective was to evaluate the relative efficacy of Ampion 4 mL versus
Ampion 10 mL. The primary endpoint was mean change in pain from baseline for
Ampion compared to the same volume of saline. Secondary endpoints included
evaluating safety and quality of life, as well as, stiffness and function.
Ampion dose cohorts experienced statistically significant reductions in pain
compared to control. There were no significant differences between the
efficacy of the two Ampion doses. Selection of the optimal dose for the second
Phase 3 trial will be decided in consultation with the U.S. Food and Drug
Michael Macaluso, Chairman and Chief Executive Officer, said, "We are very
pleased with the results of the trial. Both doses of Ampion provided
osteoarthritis patients with pain relief. The broad inclusion criteria for the
trial reflected a real world application of this biologic to a diverse patient
population, making these results even more impressive. This should greatly
encourage the enormous population of patients afflicted with OAK and the
physicians who treat them."
A brief summary of the combined Ampion topline results are as follows:
oPatients receiving Ampion achieved significantly greater reduction in pain
(WOMAC A) from baseline to 12 weeks compared to saline vehicle control(p
oPatients receiving Ampion experienced, on average, a greater than 40%
reduction in pain from baseline.
oPatients receiving Ampion also achieved significantly greater improvement
in function (WOMAC C) from baseline to 12 weeks compared to saline vehicle
control (p = 0.044).
oPatients receiving Ampion also demonstrated significantly greater
improvement in overall quality of life measures (Patient Global
Assessment) from baseline to 12 weeks compared to saline vehicle control
(p = 0.012).
oClinical efficacy defined as pain reduction was evident as early as four
weeks after the injection (p = 0.025) and continued to show improvement
through 12 weeks (p = 0.0038).
oAmpion was well tolerated with minimal adverse events (AEs) reported in
the study. AEs were well balanced between Ampion and control groups. There
were no drug-related serious adverse events (SAEs).
"This [result] is fantastic," stated Dr. Brian McGrath, principal investigator
and orthopedic surgeon at University Orthopedics Services in Amherst, New
York. "These results highlight the strong possibility that it may soon be
possible to offer patients an effective [injectable] therapy."
Dr. Nathan Wei, rheumatologist at Arthritis Treatment Center in Frederick,
Maryland, said, "I was pleasantly surprised at the positive response rate in
patients with otherwise intractable osteoarthritis of the knee. I am also
hoping to study Ampion injections into the base of the thumb and base of the
toe for which there is no current therapy."
"I am very excited to participate in the Ampion osteoarthritis trial as this
field of research seems to be finally making a difference for patients just as
rheumatoid research did ten years ago," said Dr. John Ervin, Medical Director
at The Center for Pharmaceutical Research in Kansas City, Missouri.
Mr. Macaluso further noted "Investigators will continue to monitor the
Ampion-treated patients because the data suggest improvement in pain and
function beyond the 12 week primary endpoint. Detailed 12 week data analysis
from the SPRING study will be released following discussions with the FDA and
will be presented at upcoming medical conferences."
Ampion, also known as aspartyl-alanyl diketopiperazine or DA-DKP, is an
endogenous immunomodulatory molecule derived from the N-terminus of human
serum albumin (HSA). It appears to have a significant role in the homeostasis
of inflammation. DA-DKP is believed to reduce inflammation by suppressing
pro-inflammatory cytokine production in T-cells. The non-steroidal, low
molecular weight, anti-inflammatory biologic has the potential to be used in a
wide variety of acute and chronic inflammatory conditions as well as
immune-mediated diseases. Ampio is currently developing this drug as an
intra-articular injection for the treatment of osteoarthritis of the knee.
Osteoarthritis is the most common form of arthritis, affecting over 27 million
people in the United States. It is a 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 or
hip over a lifetime is approximately 46% and 25%, respectively. 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
focused on the rapid development of therapies to treat prevalent inflammatory
conditions for which there are limited treatment options. We are developing
compounds that decrease inflammation by (i) inhibition of specific
pro-inflammatory compounds by affecting specific pathways at the protein
expression and at the transcription level (ii) activation of a specific
phosphatase or depletion of the available phosphate needed for the
inflammation process and (iii) decreasing vascular permeability – an upstream
event in the inflammation cascade.
Forward Looking Statement
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 use of words such as
"believe," "expect," "plan," "anticipate," and similar expressions. These
forward-looking statements include risks associated with clinical trials,
expected results, regulatory approvals, and changes in business conditions and
similar events. The risks and uncertainties involved include those detailed
from time to time in Ampio's filings with the Securities and Exchange
Commission, including Ampio's Annual Report on Form 10-K and Quarterly Reports
on Form 10-Q.
Director of Investor Relations
Ampio Pharmaceuticals, Inc.
Direct: (720) 437-6530
SOURCE Ampio Pharmaceuticals, Inc.
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