ENGLEWOOD, Colo., Dec. 2, 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 its
AP-014 Phase I inhaled Ampion™ clinical study in COVID-19 patients
is proceeding to full open enrollment following clearance by the
Safety Monitoring Committee (SMC), which found Ampion to be safe
and well-tolerated after reviewing results from the first three
treatment groups. The trial can now accelerate to complete
enrollment of the remaining 34 patients at the speed of
recruitment.
"The primary goal of this trial is to confirm the safety of
inhaled Ampion, so we are pleased the SMC found no concerns after
treatment of the first sets of patients," Michael Macaluso, President and CEO of Ampio
Pharmaceuticals. "The enrollment of patients will proceed quickly,
perhaps doubling the number of patients enrolled by the end of
today.
"We were also encouraged," continued Macaluso, "by a letter we
received from staff at the hospital, sharing the dramatic
improvement seen in a patient after using nebulized Ampion. Full
confirmation of Ampion's efficacy awaits the conclusion of our
clinical trial, but it is heartening to hear good news when it
comes to COVID-19."
In the trial, Ampion is 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 trial, being conducted in the
United States, 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. Since inhalation is
a new method for the administration of Ampion, cleared for clinical
use by the FDA, each of the first three patient groups receiving
inhaled Ampion were assessed by the SMC for an additional three
days after the five-day treatment period. No safety concerns arose
in any of these groups, and, as such, the trial was approved to
complete full enrollment.
In related news, the Journal of Translational Medicine
this week published a peer-reviewed paper on the method of action
of Ampion, entitled "LMWF5A suppresses cytokine release by
modulating select inflammatory transcription factor activity in
stimulated PBMC," by G. Thomas, et al. The research provides
evidence that Ampion, a low molecular weight fraction of human
serum albumin (LMWF5A), reduces pro–inflammatory cytokine release
by activating the immunoregulatory transcription factors PPARγ and
AhR while also suppressing NF–κB and STAT1α pro–inflammatory
pathways.
"This paper, in a high-impact journal, confirms that Ampion
reduces inflammation through multiple pathways, unlike many other
anti-inflammatory therapies that target only one," concluded
Macaluso. "Inflammation is one of the body's most important
survival mechanisms, so suppressing only one pathway merely forces
the body to activate other pathways. Ampion targets multiple
pathways simultaneously to interrupt the destructive cycle of
inflammation and disease observed in many different inflammatory
conditions."
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.