ENGLEWOOD, Colo., June 14, 2019 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) announced today that it
received FDA approval of the Company's special protocol assessment
(SPA) of a clinical protocol 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."
The FDA response noted "We have completed our review, and
based on the information submitted, agree that the design and
planned analysis of your study adequately address the objectives
necessary to support a regulatory submission."
The FDA continued, "However, final determinations for
marketing application approval are made after a complete review of
the marking application and are based on the entire data in the
application."
According to Michael Macaluso,
Ampio CEO, "The Company has identified and engaged 15 clinical
sites for the trial (AP-013) and patient identification is
underway. This pivotal trial seeks
to enroll approximately 1,000 patients, with an interim
look, to allow sample size adjustments, if required. This trial
will assess co-primary endpoints of pain and function. More details
of the study will be made available on clinicaltrials.gov."
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. A
SPA agreement would indicate concurrence by the FDA with the
adequacy and acceptability of specific critical elements of overall
protocol design for a study intended to support a future Biologic
License Application (BLA). The elements of the study agreed upon in
the SPA agreement are critical to ensuring that the trial conducted
under the protocol can be considered an adequate and
well-controlled study that can support marketing licensure of
Ampion. However, a SPA agreement will not indicate FDA concurrence
on every protocol detail, and the FDA may still require us to
conduct additional clinical trials in the future to support a BLA
for Ampion.
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, Inc.
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 Pharmaceutical'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," "predict," "anticipate," "will," 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 responses and decisions including the
timing thereof, the SPA, the BLA, the ability of Ampio to enter
into partnering arrangements, to initiate, conduct and report the
results of 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,
quarterly reports of Form 10-Q, periodic reports on Form 8-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
Phone: (720) 437-6500
info@ampiopharma.com
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SOURCE Ampio Pharmaceuticals, Inc.