ENGLEWOOD, Colo., April 27, 2021 /PRNewswire/ -- Ampio
Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company
focused on the advancement of immunology-based therapies for
prevalent inflammatory conditions, today revealed 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.
All patients in the study have now completed treatment, including a
follow-up at Day 28 after treatment.
The study not only met its primary endpoint, the final data
showed an even greater improvement in all-cause mortality over
patients treated using Standard of Care (SOC) than initially
reported. Mortality in the SOC group was 24%, while that in the
group treated with SOC and Ampion was only 5%, a 78% improvement in
all-cause mortality. Preliminary results had been reported in March
as 21% for SOC and 8% for Ampion, or a 62% improvement.
Other findings from the study continue to show a positive
outcome with Ampion treatment, including:
- Patients who received Ampion required less hospitalization
time. The average hospital length of stay was 4 days less for the
Ampion group compared to the patients receiving SOC
- Patients treated with Ampion were either stable or showed
improvement on a scale of clinical improvement compared to patients
treated using SOC. By day 5, 89% of patients who received Ampion
were stable or had improvement compared to 77% of patients who
received SOC. This trend in improvement with Ampion treatment is
noted as early as day 2 and continues to day 5
- Ampion treatment was safe and well-tolerated in all patients.
There were no remarkable adverse events with Ampion treatment, and
no drug-related serious adverse events were reported
"These are strong results from a Phase I trial, and we are
looking forward to continuing immediately with the commencement of
our double-blind placebo-controlled Phase II trials utilizing
Ampion in both in an inhaled form for COVID-19 respiratory distress
and intravenously for more systemic symptoms of COVID-19,"
commented Michael Macaluso,
President and CEO of Ampio. "If these Phase II studies confirm the
efficacy results seen in our Phase I trials, I can envision moving
forward quickly with an application for Emergency Use Authorization
for Ampion in treating COVID-19."
Ampio now has Investigational Review Board (IRB) approvals for
both Phase II trials and is able to begin enrolling patients in the
U.S. The Company is awaiting IRB approval for its Phase I study in
using Ampion to address the respiratory symptoms experienced by
COVID-19 Long Haulers.
In a separate release, Ampio today announced that it had
received a positive response from the U.S. Food and Drug
Administration (FDA) on its plans for its Phase III trial utilizing
intra-articular injection of Ampion for treating osteoarthritis of
the knee (OAK). The OAK trial was paused in early 2020, along with
over 1,000 other trials, because of the COVID-19 pandemic, and the
FDA was providing guidance on steps for moving forward with the
trial. Ampio will provide updates on its plans for this trial at
its upcoming May 5th earnings
call.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company
primarily focused on the advancement of immunology-based therapies
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 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 Contacts
Investor Relations
Joe
Hassett
joeh@gregoryfca.com
484-686-6600
Media Contact
Katie
Kennedy
katie@gregoryfca.com
610-731-1045
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SOURCE Ampio Pharmaceuticals, Inc.