ENGLEWOOD, Colo., Jan. 4, 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 an update on the launch of a new global clinical
trial for intravenous ("IV") treatment of COVID-19 with Ampion and
provided updates on its ongoing U.S. trial for inhalation treatment
of COVID-19.
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. The latest updates on these trials include:
- Initiation of a global clinical trial for IV treatment of
COVID-19 patients, including in out-patient settings
A global study has been initiated in Israel and the U.S. with the focus on patient
safety and efficacy, as measured by improvement in the clinical
course of the disease and related outcomes for patients with
moderate to severe COVID-19. Ampion IV treatment targets systemic
inflammation in the body of patients with moderate to severe
COVID-19 symptoms. In addition, this study will assess the effect
of Ampion IV treatment in both a hospital setting and as a therapy
for out-patient care.
- U.S. based clinical trial underway for inhalation treatment
of COVID-19 patients expands to new hospitals
A 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. The trial is currently
ongoing with no drug-related serious adverse events ("SAEs")
reported to date. The rate of enrollment is expected to increase
once requisite front-line workers receive the recently released
COVID-19 vaccines. Additional hospitals are also being added to the
inhalation study with the goal to conclude enrollment in January.
Inhaled Ampion targets inflammation in the lung and is currently
being investigated to determine whether its use will improve the
clinical outcome for patients with COVID-19. Of note, there have
been no drug-related SAEs to date in the inhaled clinical
trial.
"While the vaccine will hopefully help many people avoid the
more serious complications of COVID-19, the rollout of vaccines
will take time and is unlikely to ever reach 100% of the public,"
said Michael Macaluso, Chairman and
Chief Executive Officer of Ampio Pharmaceuticals. "We will no doubt
continue to need treatments to provide the essential relief and
improve outcomes for patients. We are especially excited to begin
the testing of Ampion for COVID-19 in an outpatient setting."
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
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SOURCE Ampio Pharmaceuticals, Inc.