ENGLEWOOD, Colo., Feb. 21, 2020 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE American: AMPE) a development stage
biopharmaceutical company, executing a Special Protocol
Assessment ("SPA") Phase III clinical trial titled "Evaluating
the Efficacy and Safety of Ampion™ to treat Adults
with Pain Due to Severe Osteoarthritis of the Knee", today
announced updates regarding the continued progress of its
Phase III AP-013 clinical trial and receipt of its annual audit
opinion.
Clinical Trial Update
The AP-013 clinical trial is
designed to evaluate the effect of Ampion on pain and function at
12-weeks in patients with severe osteoarthristis of the knee
("OAK"). This design would position Ampion as the first OAK therapy
on the market to address pain and function, and have a label and
efficacy data for the severely diseased patient population, if
approved. As of February 14, 2020 the
following had occurred:
- Of the 1,034 patients to be enrolled in AP-013, 875 patients
have been dosed with enrollment continuing to progress. Exclusions
for participation in the trial average approximately 35% in
order to ensure enrollment of only patients with severe
osteoarthritis of the knee who do not have other pain or medical
conditions that could interfere with their assessment of the pain
and function in the injected knee.
- More than 600 patients have reached the study's 12-week primary
endpoint, making the clinical trial more than 58% complete for the
primary endpoint.
Receipt of Audit Opinion with Going Concern
Qualification
The Company is required under the NYSE
American Company Guidelines Sections 401(h) and 610(b) to publish
certain disclosures. As previously disclosed within its
Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the
Securities and Exchange Commission on February 21, 2020, the Company's audited
financial statements contained a going concern explanatory
paragraph in the audit opinion from its independent registered
public accounting firm. This announcement does not represent
any change or amendment to the Company's financial statements or to
its Annual Report on Form 10-K for the fiscal year ended
December 31, 2019. A copy of
the Company's Form 10-K is located on the Company's website at
www.ampiopharma.com/investors/financial-filings. Shareholders
also have the ability to receive a hard copy of the Company's Form
10-K free of charge upon request.
About Special Protocol Assessment
A SPA is a process
in which sponsors may ask to meet with the FDA to reach an
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. Ampio's lead drug,
Ampion™, is backed by an extensive patent
portfolio with intellectual property protection extending through
2032 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 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
Daniel G.
Stokely, CFO
Phone: (720) 437-6500
info@ampiopharma.com
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SOURCE Ampio Pharmaceuticals, Inc.