ENGLEWOOD, Colo., March 24, 2020 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE American: AMPE), a pre-revenue
development stage biopharmaceutical company focused on the
development of immunology based therapies to treat prevalent
inflammatory conditions for which limited treatment options exist,
announced today that it is preparing an expanded access FDA
protocol to study potential benefit of nebulized treatment
with Ampion in SARS-Cov-2 ("COVID-19") induced Acute Respiratory
Distress Syndrome ("ARDS"), an immediately life-threatening
condition.
Ampio's Scientific Advisory Board ("SAB") members David Bar-Or,
MD, Pablo Rubinstein, MD, and
Edward Brody, MD, PhD, determined
after a careful review of the published articles on the properties
of Ampion, that nebulized Ampion may be suitable to treat another
inflammatory indication. Specifically, ARDS, one of the most
dreaded complications of COVID-19 is associated with widespread
inflammation in the lungs. The underlying mechanism of ARDS
involves diffuse injury to cells which form the barrier of the
microscopic air sacs (alveoli) of the
lung, surfactant dysfunction, and activation of
the immune system. The fluid accumulation in the lungs
associated with ARDS is partially explained by vascular leakage due
to inflammation. Ampion is an aqueous solution that may be
delivered through nebulization and may be suitable for suppressing
inflammation in the lungs.
Ampion is a human blood derived composition, currently approved
for clinical use by the FDA, as an anti-inflammatory,
immunomodulating drug. The novel mode of action of Ampion involves
multiple biochemical pathways associated with resolving
inflammation1 which make it a potential therapy for ARDS
as follows:
- An important aspect of ARDS, triggered by COVID-19, is an
initial release of chemical signals and other inflammatory
mediators secreted by lung epithelial and endothelial
cells. Neutrophils and some T-lymphocytes migrate into the inflamed
lung tissue and contribute to the amplification/deterioration of
ARDS. A decrease in the production of lipid mediators of
inflammation (prostaglandins) may impair the resolution of
inflammation associated with ARDS2,3.
- Ampion was reported to up regulate the production of these
healing lipid mediators' prostaglandins in-vitro3. In
addition, multiple inflammatory signals (i.e. TNF α, IL6, CXCL10)
have been reported to be attenuated by Ampion, including a decrease
in vascular permeability.
- More than 1,000 patients with another inflammatory disease,
osteoarthristis, have received Ampion without any serious drug
related adverse events. A subset of these patients were given
Ampion multiple times over the course of a year, and no serious
drug related adverse events were observed.
- Ampion is formulated as a sterile liquid and is easily
administered as a nebulized liquid form. If Ampion is found to be
an efficacious treatment for COVID-19 induced ARDS, the Company's
in-house manufacturing facility may allow the product to be
produced quickly and in significant quantities.
The anticipated aim of a preliminary protocol for FDA review
would be to evaluate patients with moderate to severe ARDS,
triggered by COVID-19, for (1) reduced ventilator time; (2)
reduction in mortality and (3) improvements in oxygenation
parameters compared to non-Ampion treated patients.
1 Bar-Or, et. al., On the Mechanisms of
Action of the Low Molecular Weight Fraction of Commercial Human
Serum Albumin in Osteoarthritis. Current Rheumatology Reviews,
2019, 15, 189-200.
2 Fukunaga, et. al., Cyclooxygenase 2 Plays a
Pivotal Role in the Resolution of Acute Lung Injury. Journal of
Immunology 2005; 174:5033-5039.
3 Gao et al. Resolvin D1 Improves the
Resolution of Inflammation via Activating NF-κB p50/p50-Mediated
Cyclooxygenase-2 Expression in Acute Respiratory Distress Syndrome,
174:5033-5039, J Immunol 2017
About Ampio
Pharmaceuticals
Ampio
Pharmaceuticals, Inc. is a development stage biopharmaceutical
company primarily focused on the development of Ampion to treat
prevalent inflammatory conditions for which there are limited
treatment options. Ampio's lead product candidate,
AmpionTM, is backed by an extensive patent
portfolio with intellectual property protection extending through
2032 and is 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," "may", 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, 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
Daniel G. Stokely, CFO
Phone: (720) 437-6500
info@ampiopharma.com
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SOURCE Ampio Pharmaceuticals, Inc.