ENGLEWOOD, Colo., Sept. 17, 2019 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE American: AMPE) today
announced the progress to date in the Company's special
protocol assessment (SPA) phase three clinical trial
titled, "A Randomized, Controlled, Double-Blind Study to
Evaluate the Efficacy and Safety of an Intra-Articular Injection of
Ampion in Adults with Pain Due to Severe Osteoarthritis of the
Knee."
According to Holli Cherevka,
Ampio COO, "We are pleased with the progress we have made to
date, and the recent FDA agreement to expand the number of clinical
sites in this pivotal study. The FDA has given written
guidance that prior study AP-003-A qualifies as a pivotal trial,
and that successfully passing the current study, AP-013, would
support the filing of our BLA."
- As of September
16th we have consented/enrolled 661
patients of which 423 have been injected and an additional 52 of
these patients have been approved for injection, which should take
place shortly.
- 186 of the consented patients did not meet our
inclusion/exclusion criteria (~28% of the consented) and will not
be participating in the trial. This criteria was established to
ensure that the 1,034 KL 4 patients dosed in this trial were very
closely similar in age, sex, and severity of disease to the 417 KL
4 patients in our previous single-injection trials that,
cumulatively, experienced a statistically significant reduction in
pain and improvement in function from Ampion compared to the saline
control.
- FDA has authorized the use of 8 additional clinical sites,
which will be operational by the end of September and will bring
the total number of active sites to 25.
"It is important to note," Ms. Cherevka explained, "that
in the three randomized single-injection studies previously run by
the Company, both reduction in pain and improvement in
function were greater with Ampion-treated KL 4 patients than saline
treated KL 4 patients. These results imply that had there been
increased patient enrollment, the p-values in each case would have
demonstrated a statistically significant clinical benefit with
Ampion treatment compared to saline. The Company believes the
FDA-agreed SPA trial design of the current AP-013
study addresses this issue by allowing > 1,000 KL 4
patients to be dosed. In fact, the combined results of the
prior single-injection trials indicate that the AP-013 KL 4
patients could report a difference of Ampion over saline that is
50% less than observed in the prior trials, and the clinical
benefit of Ampion in both pain and function would still be
statistically significant (p-value < 0.05)."
About Special Protocol Assessment (SPA)
A SPA is a
process in which sponsors may ask to meet with the FDA to reach
agreement on the design and size of certain clinical trials to
determine if they adequately address scientific and regulatory
requirements for a study that could support marketing approval. Our
SPA agreement for the above referenced study indicates concurrence
by the FDA with the adequacy and acceptability of specific critical
elements of overall protocol design for the study, which we intend
to support a future Biologic License Application (BLA).
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. Certain risk factors in conjunction with
natural wear and tear lead to the breakdown of cartilage. OA 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
Ampion, our product candidate, to treat prevalent inflammatory
conditions for which there are limited treatment options.
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, 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 Contact
Dan Stokely, CFO
Phone: (720) 437-6500
info@ampiopharma.com
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SOURCE Ampio Pharmaceuticals, Inc.