Applied Molecular Transport Announces First Patient Dosed in Phase 2 Study of Oral AMT-101 in Ulcerative Colitis
27 8월 2020 - 9:00PM
Applied Molecular Transport (Nasdaq: AMTI) (AMT), a clinical-stage
biopharmaceutical company, today announced that the first patient
has been dosed in a randomized, placebo-controlled, double-blind,
multicenter Phase 2a study evaluating the efficacy and safety of
oral AMT-101 in patients with moderate to severely active
ulcerative colitis (UC). AMT-101 is a gut-selective, oral,
once-daily, biologic fusion protein of interleukin 10 (IL-10) which
utilizes the company’s proprietary platform technology to harness
the power of natural active transport mechanisms for a potentially
more efficacious and safer biologic therapeutic.
“We are pleased with the speed at which we have launched this
first Phase 2 clinical trial for AMT 101 in biologic-naïve and
treatment-experienced UC patients, one trial in four that we have
planned to evaluate the broad clinical potential of our lead drug
candidate,” said Tahir Mahmood, Ph.D., chief executive officer and
co-founder of AMT. “AMT-101 is unique in that it is designed to
provide the immunomodulatory activity of IL-10 directly at the site
of active disease in the gastrointestinal tract with minimal drug
levels in the blood, lowering the risk of systemic side effects.
Beyond UC, AMT-101 has the potential to be a promising treatment in
other indications including systemic inflammatory diseases, and we
plan on initiating three additional Phase 2 studies to further
characterize its therapeutic potential.”
The Phase 2a study will include approximately 100 adult patients
with moderate to severely active UC who will be randomized 2:1 to
either receive oral AMT-101 or placebo for 12 weeks of treatment.
The global study will enroll both biologic-experienced and naïve
patients in approximately 20 countries. The primary endpoint of the
study is to assess the efficacy of repeat oral doses of AMT-101
versus placebo in reducing components of the Mayo Score at week 12.
Secondary endpoints include safety, pharmacokinetics (PK),
health-related quality of life, and markers of disease activity as
measured by symptoms, endoscopy, histology, and biomarkers.
Exploratory objectives include assessments of the pharmacodynamic
(PD) effect on inflammation and biomarkers, as well as PK
parameters in mucosal tissue.
“UC remains a very challenging condition to treat with current
therapies unable to resolve the disease in many patients. In our
successful Phase 1b study, we demonstrated that oral doses of
AMT-101 were safe and improved objective disease markers in
patients with UC after just two weeks of treatment,” said Bittoo
Kanwar, M.D., chief medical officer of AMT. “As an oral,
gut-selective immunomodulatory biologic therapy, AMT-101 could
significantly improve the lives of patients with UC.”
About AMT-101 AMT-101 is a GI-selective, oral
fusion of rhIL-10 and its proprietary carrier molecule, which has
been evaluated in a Phase 1b trial in ulcerative colitis (UC).
AMT-101 is designed to cross the intestinal epithelium (IE) barrier
while not entering the bloodstream, thereby focusing the drug
directly at the site of action of the underlying biology of the
disease in 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, a disease with approximately 2.2 to 2.4 million patients in
the United States and Europe according to a 2014 report. As a
locally-targeted, GI-selective biologic therapeutic, AMT-101 has
potential use in a variety of inflammatory indications beyond
UC.
About Ulcerative Colitis Ulcerative colitis
(UC) is an inflammatory autoimmune disease of the gastrointestinal
(GI) tract that manifests through complex interactions between the
gut microbiome, dysregulated immune responses, genetic mutations,
diet, and other environmental factors. As a result, the precise
etiology for disease initiation differs widely among patients with
UC. 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. 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
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 intestinal
epithelium (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 oral biologic product candidates in patient-friendly
tablet and capsule forms that are designed for either targeting
local gastrointestinal (GI) tissue or entering systemic circulation
to precisely address the relevant biology of a disease. AMT is
building a portfolio of oral product candidates based on its
technology platform including its lead product candidate, AMT-101,
an oral GI-selective interleukin 10 that has completed a Phase 1b
clinical trial in patients with ulcerative colitis (UC). AMT
further plans to initiate Phase 2 clinical trials of AMT-101 in UC
and related inflammatory indications. AMT’s technology platform
enables it to design and develop various oral biologic therapeutic
modalities, such as peptides, proteins, full-length antibodies,
antibody fragments, and RNA therapeutics, with potentially
significant advantages over existing marketed and development-stage
drugs.
Forward-Looking Statements This 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 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 AMT’s
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (the “SEC”) on August 11, 2020, and AMT’s
future reports to be filed with the SEC. 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.
Contacts: Sylvia WheelerPrincipal, Wheelhouse
Life Science Advisorsswheeler@wheelhouselsa.com
Alexandra SantosSenior Partner, Wheelhouse Life Science
Advisorsasantos@wheelhouselsa.com
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