ENGLEWOOD, Colo., March 16, 2021 /PRNewswire/ -- Ampio
Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company
focused on the advancement of immunology-based therapies for
prevalent inflammatory conditions, recently revealed preliminary
positive results in its AP-014 Phase I clinical trial utilizing
inhaled Ampion in treating respiratory distress in patients as a
result of COVID-19. The Company also outlined its progress toward
initiating a Phase I clinical trial using inhaled Ampion for
treating those suffering lingering respiratory effects after
COVID-19 infection, the so-called COVID-19 "long haulers," as well
as its continued research focusing on the use of Ampion in kidney
and pediatric diseases.
"We shared these promising results with the FDA in our recent
request to expand that trial. The FDA's response recommended that
we forego our planned unblinded expansion of the current trial and
move directly to a randomized, double-blinded, placebo-controlled
Phase II study of inhaled Ampion in COVID-19," said Michael Macaluso, Chairman and Chief Executive
Officer of Ampio Pharmaceuticals. "It is also important to note
that the data was presented to the FDA for guidance as a potential
Emergency Use Authorization (EUA) therapy."
Preliminary results from the AP-014 Phase I trial of inhaled
- Ampion demonstrated an improvement in all-cause mortality in
COVID-19 patients compared to standard of care (SOC). A lower
all-cause mortality rate of 8% is observed for the Ampion treatment
group, compared to 21% in standard of care alone.
- Patients who received Ampion required less hospitalization
time. The average hospital length of stay was 7 days for the
Ampion group compared to 11 days for standard of care
- Patients who received Ampion required less oxygen than
standard of care alone, and 86% of Ampion patients were stable or
had improvement compared to 75% of SOC patients.
- More patients who received Ampion were stable or had
improvement on a scale of clinical improvement compared to
standard of care alone. By day 5, 86% of patients who received
Ampion were stable or had improvement compared to 75% of standard
of care patients. This trend in improvement with Ampion treatment
is noted as early as day 2 and continues to day 5.
- Adverse events were the same between Ampion and standard of
care, and no drug-related serious adverse events have been
In commenting on the preliminary positive results in the AP-014
Phase I clinical trial of inhaled Ampion, Dr. David Cornutt, MD, Chairman, Department of
Emergency Medicine, Regional West Health Services, and a Medical
Monitor on the study, said, "The scientific findings we have
reviewed thus far are fascinating and very encouraging. While we
are still looking at preliminary data from a small sample size, the
safety signals look strong, and I look forward to moving into the
efficacy phases to come."
Initiating trial in "long hauler" COVID-19
Ampio also provided details on its forthcoming Phase I clinical
trial utilizing inhaled Ampion with patients exhibiting "long
hauler" COVID-19 symptoms, now known clinically as Post-Acute
Sequelae of SARS-CoV-2, or PASC. A significant percentage of the
millions of people who have contracted COVID-19 over the past year
– even those with mild or asymptomatic cases – continue to suffer
effects from the disease long after there is no detectable virus in
"The complications from COVID-19 stem not from the virus but
from the out-of-control inflammatory immune response it triggers,
which remains a problem long after the infection is over. We
believe that inhaled Ampion could provide a significant therapeutic
benefit for those patients plagued by PASC ("long haul symptoms"),"
continued Macaluso. "And, because Ampion is a platform biologic,
what we learn in our upcoming trial could be applicable to a
significant number of diseases displaying similar inflammatory-type
characteristics, not just COVID-19."
The trial design will deal specifically with respiratory
distress-related symptoms and will involve an "at home" treatment,
where patients will receive a nebulizer and a five-day supply of
inhaled Ampion. The trial protocol is currently being finalized,
with commencement of the study expected by mid-Q2 2021.
Update on research into kidney and pediatric diseases
In collaboration with physician scientists at Vanderbilt University, Ampio is studying the
effects of Ampion on inflammation in kidney function, as most
kidney disorders involve inflammation. The preclinical research is
being done in vitro on renal endothelial cells as well as on
proximal tubular epithelial cells of the kidney, all cells involved
in the pathophysiology of kidney inflammation.
"The results so far are promising," commented David Bar-Or, MD,
Director and Founder of Ampio Pharmaceuticals, "as Ampion's method
of action aligns both theoretically and is confirmed by initial
in vitro experiments on those cells."
Ampio is also conducting research into the potential use of
Ampion in treating post-Fontan protein-losing enteropathy in
conjunction with clinicians and scientists at a major children's
hospital based in Philadelphia.
The Fontan procedure is a cardiac surgery performed on children
born with a single chamber in their heart. Essentially, the
procedure involves separating the venous from the arterial blood.
Some of these children develop a post-procedure condition termed
protein-losing enteropathy, which can be so severe that it
necessitates a heart transplant.
"The cause of this condition is unclear and involves several
theories," continued Dr. Bar-Or. "One theory involves inflammation,
and we are studying this angle by performing complex in
silico work on available genomics, micro-RNA, and other data
sets to determine the potential molecular pathways involved. We are
also undertaking in vitro experiments on lymphatic
endothelial cells permeability, intestinal epithelial cells and
others to demonstrate the potential beneficial effect of Ampion in
this condition. This may lead to a treatment option for this
dreadful condition affecting young children."
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 2035 and will be
eligible for 12-year FDA market exclusivity upon approval as a
novel biologic under the biologics price competition and innovation
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
View original content to download
SOURCE Ampio Pharmaceuticals, Inc.