Applied Molecular Transport Announces Publication of Preclinical Data Demonstrating Potential of Novel Oral IL-10 Biologic Th...
2020年11月10日 - 10:00PM
Applied Molecular Transport (Nasdaq: AMTI) (AMT), a clinical-stage
biopharmaceutical company, today announced that the unique
mechanism of action of AMT-101 and preclinical data supporting its
potential as a treatment for ulcerative colitis (UC), and other
inflammatory diseases, have been published in The Journal of
Immunology. The article entitled, “A Novel Fusion of Interleukin-10
Engineered to Traffic Across Intestinal Epithelium to Treat
Colitis” was published in the November 2020 online edition of The
Journal of Immunology.
The research published in The Journal of Immunology highlights
how AMT’s proprietary technology platform exploits existing natural
cellular trafficking pathways to actively transport therapeutics
through the intestinal barrier directly into the underlying
immune-rich milieu of the lamina propria. IL-10 is a potent
immunomodulatory cytokine with significant therapeutic potential in
intestinal inflammatory diseases as well as in those associated
with systemic inflammation. However, clinical utilization of IL-10
to treat inflammation and immune-dysregulation has been limited due
to side effects associated with systemic administration.
“Our breakthrough platform technology enables the active
transport of oral biologics by solving the long-standing industry
challenge of transporting large, biologically-active molecules
efficiently across the intestinal barrier,” said Randall Mrsny,
Ph.D., chief scientific officer and co-founder of AMT. “Our
technology platform is based on native, active vesicular
transcytosis mechanisms to rapidly and efficiently traverse
intestinal epithelial cells. Once across this epithelia barrier and
in the underlying intestinal lamina propria, AMT-101 targets local
macrophages and lymphocytes to activate cell signaling pathways,
inducing tissue and circulating markers demonstrating IL-10
mechanism of action through cognate receptor engagement and
down-stream signaling. Importantly, we continue to leverage our
technology platform to be a robust engine for the design and
development of a wide range of oral biologic therapeutics.”
In vitro and in vivo characterization of AMT-101 demonstrated
its ability to efficiently cross the human intestinal epithelium by
an active, receptor-mediated vesicular transcytosis process,
activating IL-10 receptor signaling to increase cellular
phospho-STAT3 (pSTAT3) levels in macrophage cells. In models of
induced colitis, AMT-101 was able to rectify pathologic changes by
suppressing pro-inflammatory markers of disease while inducing
anti-inflammatory cytokines, both locally in the intestinal tissue
as well as in plasma.
“Our preclinical data has also shown that oral hIL-10 can be
targeted to the intestinal lamina propria with minimal systemic PK,
suggesting that we may be able treat IBD patients with fewer
toxicities than previously observed following the systemic
administration of this potent cytokine,” said Tahir Mahmood, PhD,
chief executive officer and co-founder of AMT. “We have evaluated
AMT-101 in active ulcerative colitis patients in a Phase 1b study
and demonstrated reductions in objective clinical measures of
intestinal inflammation such as fecal calprotectin and
histopathologic scores, as well as systemic indicators of
inflammation such as C-reactive protein, after just 14 days of
treatment. We are excited about our ongoing and planned Phase 2
trials for AMT-101 in IBD and rheumatoid arthritis and will
continue to leverage the platform to build our pipeline of
differentiated oral biologic therapeutics.”
About AMT-101AMT-101 is a GI-selective, oral
fusion of hIL-10 and its proprietary carrier molecule, which is
currently being developed in four Phase 2 clinical trials in
inflammatory bowel diseases and rheumatoid arthritis. AMT-101 is
designed to cross the intestinal epithelium (IE) barrier with
limited entry into the bloodstream, thereby focusing hIL-10 in the
lamina propria of the gastrointestinal (GI) tissue and, therefore,
potentially avoiding the side effects observed with systemic
administration. By design, AMT-101 is actively transported through
the IE barrier into the GI tissue, the primary site of inflammation
in UC.
About Ulcerative ColitisUlcerative colitis (UC)
is an inflammatory autoimmune disease of the GI tract with
approximately 2.2 to 2.4 million patients in the United States and
Europe according to a 2014 report. Current therapies for UC have
significant adverse side effects including systemic
immunosuppression, increased incidence of opportunistic and rare
infections, and increased risk for cancer. Furthermore,
approximately half of UC patients will relapse in any given year,
including a minority with frequently relapsing or chronic,
continuous disease and approximately 15.6% of UC patients will
undergo surgery within 10 years of diagnosis, with 20% to 30% of
patients ultimately proceeding to surgical colectomy. In addition,
UC may have a profound effect on quality of life, including mental
health consequences, and a significant minority of patients become
incapable of work due to disease. Thus, there remains a significant
and unmet clinical need to better manage UC with safer and more
effective oral therapies.
About Applied Molecular Transport Inc.Applied
Molecular Transport Inc. is a clinical-stage biopharmaceutical
company leveraging its proprietary technology platform to design
and develop a pipeline of novel oral biologic product candidates to
treat autoimmune, inflammatory, metabolic, and other diseases.
AMT’s proprietary technology platform allows it to exploit existing
natural cellular trafficking pathways to facilitate the active
transport of diverse therapeutic modalities across the IE barrier.
Active transport is an efficient mechanism that uses the cell’s own
machinery to transport materials across the IE barrier. AMT
believes that its ability to exploit this mechanism is a key
differentiator of its approach. AMT is developing additional oral
biologic product candidates in patient-friendly tablet and capsule
forms that are designed to either target local GI tissue or enter
systemic circulation to precisely address the relevant biology of a
disease.
AMT’s headquarters, internal GMP manufacturing and lab
facilities are located in South San Francisco, CA. For additional
information on AMT, please visit www.appliedmt.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Forward-looking
statements generally relate to future events or AMT’s future plans,
strategy and performance. Such statements include, but are not
limited to, the potential of, and expectations regarding AMT’s
technology platform and AMT-101, statements regarding AMT’s Phase 2
clinical trials for AMT-101 including the timing of such trials,
AMT’s ability to leverage its technology to expand its pipeline,
and the unmet clinical need to better manage UC. Such statements
are subject to numerous important factors, risks and uncertainties
that may cause actual events or results to differ materially,
including those more fully described under the section entitled
“Risk Factors” in documents the company files from time to time
with the Securities and Exchange Commission. These forward-looking
statements are made as of the date of this press release, and AMT
assumes no obligation to update the forward-looking statements, or
to update the reasons why actual results could differ from those
projected in the forward-looking statements, except as required by
law.
Investor Relations
Contact:Andrew ChangHead, Investor Relations &
Corporate Communicationsachang@appliedmt.com
Media Contacts:Sylvia
WheelerPrincipal, Wheelhouse Life Science
Advisorsswheeler@wheelhouselsa.com
Alexandra SantosSenior Partner, Wheelhouse Life Science
Advisorsasantos@wheelhouselsa.com
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