ENGLEWOOD, Colo., Oct. 28, 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 the Company has begun recruiting and enrolling patients
in a Phase I multi-center, randomized, controlled trial for a
total of 40 patients that will assess the safety and efficacy of
inhaled Ampion added to the standard of care ("SOC") for
COVID-19 infected patients hospitalized for respiratory distress.
Dosing of patients will begin at Penrose Hospital in Colorado Springs, Colorado and will expand
enrollment to other hospitals in the near future.
Michael Macaluso, Ampio's CEO
clarified specific features of this clinical trial:
- Ampion will be administered to COVID-19 patients by inhalation,
allowing the drug to directly target and attenuate inflammation in
the lungs, as administered by either a hand-held nebulizer for
COVID-19 patients with mild to moderate disease, or by non-invasive
ventilation (face mask) and mechanical ventilation (intubation) in
patients impacted with more severe disease.
- This US study will enroll 40 patients, randomized 1 to 1,
Ampion in addition to SOC versus SOC alone. Each patient in the
treatment arm will inhale 8 mL doses of Ampion four (4) times a day
for five (5) days. Safety is the primary end-point and various
measurements indicative of efficacy are secondary endpoints.
- The first three patients inhaling Ampion will be assessed by a
Safety Monitoring Committee for an additional three days after the
5 day treatment period, as required by the protocol, as inhalation
is a new method of administration of Ampion approved for clinical
use by the FDA. If no safety concerns arise, then open enrollment
at the speed of recruitment will follow for the remaining
patients.
Mr. Macaluso further noted " The FDA has now granted two
separate INDs and protocols of administration of Ampion for the
treatment for COVID-19 patients, inhalation and intravenous, and a
third method of administration, by direct intra-articular injection
into the knee for patients suffering from severe
osteoarthritis-of-the-knee. These various indications and modes of
administration of Ampion strengthens the Company's belief that
Ampion is a platform drug, which is potentially useful for a number
of additional inflammatory conditions. We are currently
investigating the possibility of conducting a series of similar
inhalation studies world-wide that would run concurrently with the
US study. We will provide an update to our shareholders with more
information as it develops."
About Ampio Pharmaceutical
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
Dan Stokely, CFO
Phone: (720) 437-6500
info@ampiopharma.com
Ampio Pharmaceuticals, Inc.
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SOURCE Ampio Pharmaceuticals, Inc.