ENGLEWOOD, Colo., May 10, 2021 /PRNewswire/ -- Ampio
Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company
focused on the advancement of immunology-based therapies for
prevalent inflammatory conditions for which there are limited
treatment options, today announced that it has received
Investigational Review Board (IRB) approval to commence enrollment
in its AP-018 Phase I study using inhaled Ampion™ with patients
exhibiting prolonged respiratory COVID-19 symptoms, known as long
(or long-haul) COVID, or Post-Acute Sequelae of SARS-CoV-2.
"This trial is both needed and exciting in that it addresses
a major current and expected ongoing unmet medical need among the
estimated 3 to 10 million individuals currently suffering from long
COVID," said Michael Macaluso,
President and CEO of Ampio. "A significant percentage of
patients who have contracted COVID-19 over the past year – even
those with mild or asymptomatic cases – continue to suffer
debilitating effects long after there is no detectable virus in
their system. These symptoms stem from the out-of-control
inflammatory immune response the virus triggers, something Ampion
may be able to address."
The trial will be led by Principal Investigator Michael J. Barber, MD, PhD, FACC, FHRS, FAHA,
who has more than 36 years of practice as a board-certified
Internist, Cardiologist and Electrophysiologist and is the Director
of Medical, Cardiovascular and Intravenous Nutritional Services for
the Strata Integrated Wellness Spa.
In commenting on his role as Principal Investigator of the
study, Dr. Michael Barber said,
"Patients suffering from long COVID have a serious need for
treatments, yet little research has been done so far. We look
forward to exploring the anti-inflammatory effects of Ampion in
patients suffering from long COVID."
The Phase 1 study, "A Randomized, Double-Blinded,
Placebo-Controlled Phase I Study to Evaluate the Safety and
Efficacy of Ampion in Patients with Prolonged Respiratory Symptoms
due to COVID-19 (Long-COVID)," is to evaluate the safety and
efficacy of inhaled Ampion in adults with prolonged respiratory
complications after COVID-19 infection. Thirty (30) participants
with a confirmed, symptomatic COVID-19 diagnosis who continue to
experience at least two COVID-19 respiratory symptoms will be
randomized in one of two groups, active or placebo control. Both
groups will be given a nebulizer to use at home for five days.
Participants will be followed for 60 days after treatment.
The primary endpoint of the study is the incidence and severity
of adverse events (AEs) and serious adverse events (SAEs) from
baseline to Day 28 and Day 60. Exploratory efficacy endpoints also
assess the effect of inhaled Ampion compared to placebo on the
clinical outcomes for participants with prolonged respiratory
complications after a COVID-19 infection. Details on the study will
be found on clinicaltrials.gov, once posted.
Relevant Recent History
On April 27, 2021, the company
reported that all patients in its AP-014 Phase I trial of inhaled
Ampion for COVID-19 have completed treatment, including a follow-up
at Day 28 after completion of treatment. The study not only met its
primary endpoint of safety and tolerability, but final data showed
that Ampion reduced all-cause mortality in COVID-19 respiratory
distress by 78% over the Standard of Care (SOC) for COVID-19
respiratory distress. Specifically, mortality in the SOC group was
24%, while in the group treated with Ampion, mortality was only
5%.
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.
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.