ENGLEWOOD, Colo., Dec. 29, 2020 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical
company focused on the advancement of immunology-based therapies
for prevalent inflammatory conditions, announced today it has
received guidance from the U.S Food & Drug Administration
("FDA") regarding the impact of COVID-19 on its Phase III clinical
trial for osteoarthritis of the knee ("OAK").
The COVID-19 health emergency has impacted clinical trials, with
over 1,000 studies suspended as a result of the pandemic, including
the Phase III clinical trial ("AP-013") for the intra-articular
injection of Ampion for treatment of severe OAK. The AP-013 study
is being conducted under a Special Protocol Assessment ("SPA")
which provides a documented framework for communication and gaining
agreement with the FDA to support a commercial Biologics Licensing
Application ("BLA").
In their feedback, the FDA agrees that OAK is a highly
prevalent condition that affects millions of patients in
the United States. In addition,
the FDA provided practical guidance for the AP-013 study to
navigate the pandemic, and to complete the study without re-running
the trial. The FDA options give us the opportunity to provide
additional evidence to support the use of existing data and/or add
more patients to the trial. Ampio is thankful for this flexibility,
is considering all options and is working to find a solution that
will allow us to proceed despite COVID-19 and will present our
analysis and proposal to the FDA as soon as possible.
Answers to questions are available on our website by clicking on
the link below:
https://ampiopharma.com/news/latest-news/
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 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, the ability to
receive regulatory approval to conduct clinical trials, that Ampion
may be used to treat ARDS induced by COVID-19, 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
Investor Relations
Joe Hassett
joeh@gregoryfca.com
484-686-6600
Media Contact
Sarah
May
sarahm@gregoryfca.com
215-205-1217
View original content to download
multimedia:http://www.prnewswire.com/news-releases/ampio-receives-feedback-from-the-fda-on-ampios-proposed-modifications-to-the-special-protocol-assessment-for-ampion-treatment-of-severe-osteoarthritis-of-the-knee-301198986.html
SOURCE Ampio Pharmaceuticals, Inc.