ENGLEWOOD, Colo., Jan. 14, 2021 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical
company focused on the advancement of immunology-based therapies
for prevalent inflammatory conditions, today announced its ongoing
U.S. Phase I clinical trial for inhalation treatment of COVID-19
with Ampion (AP-014) is 55% enrolled.
The Phase I clinical trial is ongoing, with the primary focus to
evaluate the impact of inhaled Ampion treatment in patients with
respiratory distress due to COVID-19. Inhaled Ampion specifically
targets inflammation in the lung and is currently being
investigated to determine whether its use will improve the clinical
outcome for patients with respiratory distress due to COVID-19.
"We've received amazing feedback from healthcare providers about
the improvement seen in patients receiving inhaled Ampion," said
Mike Macaluso, CEO of Ampio
Pharmaceuticals. "We continue to remain very optimistic at the
early, anecdotal evidence regarding the clinical effectiveness of
inhaled Ampion in COVID-19 patients, and eagerly await the full
results of this trial."
"Our experience using inhaled Ampion to treat patients with
COVID-19 continues to trend positively showing no serious
drug-related adverse effects," said Chief of Medical Staff for
Penrose-St. Francis Health Services Michael Roshon, MD, PhD. "We
look forward to seeing the full results of the study as
therapeutics for COVID-19 continue to be in high demand."
More than 22 million people in the
United States have been diagnosed with COVID-19, making up
nearly a quarter of the cases worldwide. Despite the growing
availability of vaccines, therapeutics are and will continue to be
necessary to treat patients suffering from some of the virus' most
challenging and damaging effects, including, but not limited to,
systemic inflammation in the lungs.
Currently, the study of inhaled Ampion in COVID-19 patients has
exhibited no drug-related serious adverse events (SAE). Feedback
from the Safety Monitoring Committee (SMC), analyzing any safety
concerns related to inhaled Ampion, is expected later this
month.
In vitro, Ampion interrupts the hyper-active immune
response, known as the cytokine storm, which is directly associated
with the more serious symptoms of COVID-19. The benefit of this
effect from Ampion is currently being studied in multiple human
clinical trials. In addition to the U.S. based trial of inhaled
Ampion, Ampio Pharmaceuticals has initiated a global study
commencing in Israel and the U.S.
for patients with moderate to severe COVID-19, assessing the safety
and efficacy of intravenous Ampion treatment in both a hospital
setting and as a therapy for out-patient care.
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-pharmaceuticals-ongoing-phase-i-clinical-trial-for-inhalation-treatment-of-covid-19-with-ampion-is-55-enrolled-301208409.html
SOURCE Ampio Pharmaceuticals, Inc.