ENGLEWOOD, Colo., March 24, 2020 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE American: AMPE; the "Company"), a
pre-revenue development stage biopharmaceutical company
announced today that it has suspended patient enrollment in its
Phase 3 clinical trial of Ampion ("AP-013") for the treatment
of severe osteoarthritis of the knee ("OAK"). The trial focuses on
individuals with the most severely diseased OAK, which represents
an underserved patient population typically excluded from clinical
studies because of the intractable nature of their condition. The
average and maximum age of a patient in the AP-013 clinical trial
is 65 and 87 years old, respectively. The Centers for Disease
Control and Prevention ("CDC") have indicated that older adults, 65
years and older, are at higher risk for severe illness during the
current COVID-19 pandemic.
The Safety Monitoring Committee ("SMC") for the AP-013 clinical
trial has unanimously recommended, following an interim analysis
and due to extenuating circumstances relating to the COVID-19
virus, to minimize risk to study participants that, "The study
cease enrolling patients because the number of injected patients,
1,019, is sufficiently close to the number of patients called for
by the sample size re-estimation algorithm, 1,034."
The Federal Drug Administration ("FDA") has recognized that
challenges may arise, for example, from quarantines, site closures,
travel limitations, and/or other considerations due to the
pandemic. The Contract Research Organization ("CRO") running the
AP-013 clinical trial for the Company has notified the Company that
due to the COVID-19 virus, all travel has been suspended for
clinical study monitors, which severely limits our ability to
monitor the conduct of the AP-013 clinical trial. Recognizing
these challenges, the Company is exploring options to enable it to
complete the trial but notes that it is possible that the COVID-19
pandemic may prevent completion of the AP-013 trial at this time or
at all.
Concurrently, the Company is focusing on investigating the
potential use of nebulized Ampion for the treatment of a serious
complication of COVID-19, the rapid onset of respiratory failure,
termed Acute Respiratory Distress Syndrome ("ARDS"). Based on
Ampion's immunomodulatory and anti-inflammatory action, we believe
that it may help individuals with widespread inflammation in the
lungs and may reduce this serious complication of COVID-19.
About Osteoarthritis
Osteoarthritis ("OA") is an incurable and progressive disorder of
the joint 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 to treat prevalent
inflammatory conditions for which there are limited treatment
options. Ampio's lead product candidate, AmpionTM,
is backed by an extensive patent portfolio with intellectual
property protection extending through 2032 and is 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 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
Daniel G. Stokely, CFO
Phone: (720) 437-6500
info@ampiopharma.com
View original content to download
multimedia:http://www.prnewswire.com/news-releases/ampio-suspends-patient-enrollment-in-its-phase-3-study-of-ampion-for-severe-osteoarthritis-of-the-knee-and-explores-other-options-to-complete-trial-301028683.html
SOURCE Ampio Pharmaceuticals, Inc.