ENGLEWOOD, Colo., Dec. 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 it has completed its Phase I clinical trial and has
initiated the first steps for a global Phase II clinical trial for
intravenous ("IV") Ampion treatment in COVID-19 patients.
The Phase I study was a randomized, controlled study of adults
hospitalized with severe COVID-19. The primary endpoint for
the study was evaluated after a 5-day treatment period, and safety
was followed for an additional 3 months. Half of the patients
received IV Ampion plus the standard of care ("SOC") for COVID-19
while the other half received SOC alone. The following highlights
- Based on data review, the Safety Monitoring Committee ("SMC")
found the IV treatment of Ampion to be safe and well-tolerated for
90-days following treatment.
- The study met its primary safety endpoint after 5 days of IV
Ampion treatment and again after 3 months, with no remarkable
safety differences between the Ampion treatment and SOC control
- The study showed promising efficacy with the IV Ampion
treatment group seeing stronger clinical improvement than the SOC
group as measured by the World Health Organization ("WHO") clinical
improvement scale and the National Early Warning Score ("NEWS2"),
which is recommended by the National Institute for Health and Care
Excellence ("NICE") in its guidelines for the management of
COVID-19 patients in critical care.
- Additionally, Ampion-treated patients showed greater
improvement compared to patients treated with the SOC, including
The beneficial clinical applications for IV Ampion treatment in
COVID-19 patients will be further explored using two treatment
groups in a larger Phase II study while building on the safety
profile from the Phase I study. The following highlights are
- Clinical sites in Israel will
be used concurrently with sites in the
United States, as Israel
has been recognized by the FDA as capable for sharing knowledge and
inspection information to support the safety and efficacy of drugs
in the United States.
- In vitro, Ampion interrupts the hyper-active immune
response, known as the cytokine storm, associated with COVID-19
infection. IV Ampion targets systemic inflammation in the
body observed with COVID-19 patients, which is being
investigated to improve the clinical course of the diseases and
outcomes in patients treated with Ampion.
- The IV Ampion clinical program complements ongoing clinical
studies evaluating inhaled Ampion, which targets localized
inflammation in the lungs.
About 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.
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SOURCE Ampio Pharmaceuticals, Inc.