ENGLEWOOD, Colo., April 19, 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 findings of pre-clinical
research demonstrating that Ampio's lead drug candidate, Ampion™,
provides some of the same anti-inflammatory effects as the steroid
dexamethasone but without the significant adverse events associated
with steroids.
"Steroids such as dexamethasone are globally immunosuppressive,
to both innate and adaptive immune systems, with effects that are
beneficial in the short term and often harmful long-term," said
David Bar-Or, M.D., Director and Founder of Ampio
Pharmaceuticals.
"Our research looked at the gene-level interactions of both
Ampion and dexamethasone in immunostimulated peripheral blood
monocytes, or PBMCs," continued Bar-Or, "and it became clear that
Ampion regulated some of the same inflammation-associated genes as
dexamethasone, though through disparate mechanisms of action. This
may explain Ampion's ability to mimic the anti-inflammatory effects
of steroids without causing similar adverse effects."
Michael Macaluso, President and
CEO of Ampio, commented, "The coronavirus pandemic has highlighted
the critical need for medical innovation. The potential
availability of an anti-inflammatory therapy that provides many of
the same benefits of dexamethasone without the similar adverse
effects of long-term use would be a boon for patients suffering
from debilitating and often life-threatening inflammatory
disease."
The research highlighted key similarities and differences
between Ampion and dexamethasone.
Similarities between Ampion and Dexamethasone
In the three different immunostimulation conditions used to
evaluate Ampion's effect on PBMCs, Ampion regulated 102 of the same
transcripts as dexamethasone according to RNA sequencing and
differential gene expression analysis performed with Ingenuity
Pathway Analysis (IPA) software from QIAGEN Digital Insights.
Further, overall IPA modeling predicted significantly similar
regulation of downstream molecules by dexamethasone and Ampion
based on directionally correlated transcripts. A comparison showed
that, in each immunostimulatory condition, transcripts regulated by
Ampion significantly overlapped with transcripts regulated by
dexamethasone.
"Ampion acts as an anti-inflammatory drug with some important
overlapping effects also provided by dexamethasone," explained
Bar-Or.
Differences between Ampion and Dexamethasone
However, there were some significant differences seen between
Ampion and dexamethasone. Based on IPA computational modeling,
there were 30 transcripts where Ampion's activity was different
than known regulation by dexamethasone – up regulating when
dexamethasone was down, or vice versa – in at least one of
the treatment conditions. Dexamethasone also targets a wide range
of molecules that are not regulated by Ampion.
"These observations may help to explain, in addition to the
different modes of action of the two drugs, why patients treated
with Ampion do not suffer the same adverse effects as those treated
with dexamethasone," said Bar-Or.
The absence of significant adverse effects in the large numbers
of patients administered Ampion – by intra-articular injection,
intravenous administration, and inhalation, and now supported by
multi-omics (genomics, transcriptomics, proteomics and
metabolomics) analysis and IPA modeling of the Mechanism of Action
(MOA) of Ampion compared to corticosteroids, provides an
encouraging foundation for the ongoing clinical investigations of
Ampion in a wide range of inflammatory conditions.
"In essence," concluded Bar-Or, "this evidence suggests that
Ampion is an anti-inflammatory drug with some important overlapping
effects provided by dexamethasone but without the significant
adverse events associated with steroids."
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a 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 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.