ENGLEWOOD, Colo., Nov. 25, 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 the following updates:
- Patients experiencing respiratory distress due to COVID-19:
In the Phase I inhaled Ampion™ clinical trial
(AP-014), the third of three initial safety groups of
patients have completed their five days of treatment and three
days of follow up for Safety Monitoring Committee (SMC) review
(as inhalation is a new delivery method of Ampion cleared for
clinical use by the FDA). Once the SMC provides confirmation
regarding no safety concerns for this third group, the trial will
accelerate to complete the remaining thirty-four patients at the
speed of recruitment with additional hospital groups added as
required to support enrollment.
- Patients with severe osteoarthritis of the knee
(OAK): The amendment to the OAK Phase III clinical trial
(AP-013), that harmonizes the FDA agreement on the Special Protocol
Assessment (SPA) with FDA guidance for clinical trials on hold due
to COVID-19, has been received by the FDA. The FDA notified the
Company that a formal response will be provided by the end of this
year.
About Ampio Pharmaceutical
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 United States
Private Securities Litigation Reform Act of 1995, as amended to
date. 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 the
safety and efficacy of Ampion and its classification, as well as
those associated with regulatory approvals and other FDA decisions,
the Biologics License Application (BLA), the ability of Ampio to
enter into partnering or licensing arrangements, current or
future clinical trials, changes in business conditions and similar
events (including currently unforeseen risks associated with
COVID-19), the possibility that Ampion may be used to treat ARDS
induced by COVID-19, Ampio's ability to continue as a going concern
and its ability to continue to raise funds using its
"at-the-market" equity offering or otherwise, 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, in Ampio's Annual Report on Form 10-K
for the period ended December 31, 2019, and in subsequent
reports on Forms 10-Q and 8-K and other filings made by Ampio with
the Securities and Exchange Commission. Accordingly, you should not
place undue reliance on these forward-looking statements. 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 Relations
Sarah May
sarahm@gregoryfca.com
215-205-1217
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SOURCE Ampio Pharmaceuticals, Inc.