ENGLEWOOD, Colo., Nov. 17, 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 that the third group in the Phase I inhaled
Ampion™ clinical study is being treated following clearance by
the Safety Monitoring Committee (SMC) who found Ampion to be safe
and well-tolerated after reviewing the results from the first and
second treatment groups.
Michael Macaluso, Ampio's,
President and CEO, clarified specific features of this clinical
trial:
- "Ampion is being administered to patients by inhalation,
allowing the drug to directly target and attenuate inflammation in
the lungs, using a hand-held nebulizer for COVID-19 patients early
in the disease and non-invasive ventilation (face mask) and
mechanical ventilation (intubation) if their disease state is more
severe.
- This US based study will enroll 40 patients, randomized 1 to 1,
inhaled Ampion versus Standard of Care (SOC), with each patient
inhaling 8 ml doses of Ampion four (4) times a day for five (5)
days. Safety is the primary end point and various measurements
indicative of efficacy are secondary endpoints.
- Each of the first three patient groups receiving inhaled Ampion
are assessed by the SMC for an additional three days after the 5
day treatment period (as inhalation is a new method of
administration of Ampion cleared for clinical use by the FDA) and
if no safety concerns arise for this third group, the trial will
accelerate to complete enrollment of the remaining 34 patients at
the speed of recruitment."
Mr. Macaluso further noted, "The FDA has now cleared two types
of administration of Ampion (i.e., inhalation and intravenous) for
treatment of COVID-19 patients. In addition, a third method of
administration, direct injection into the knee for patients
suffering from severe osteoarthritis of the knee, supports the
Company's belief that Ampion is a platform drug, potentially useful
for a number of inflammatory diseases throughout the body. We
are continuing our investigation of conducting a similar
inhalation study overseas that we expect will run in close
proximity with the US study. We will provide an update with more
information as it develops."
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.