Applied Molecular Transport Expands Clinical Pipeline and Announces First Subject Dosed in Phase 1a Trial of Oral AMT-126
01 3월 2021 - 10:00PM
Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a
clinical-stage biopharmaceutical company, today announced the first
in human dosing in its Phase 1a clinical trial of oral AMT-126. The
randomized, placebo controlled, single ascending dose Phase 1a
trial is evaluating the safety, tolerability, pharmacodynamics and
pharmacokinetics of AMT-126, a novel, gastrointestinal
(GI)-selective oral fusion of human interleukin-22 (hIL-22), in up
to 50 healthy volunteers.
“We have rapidly advanced into the clinic our
second novel program leveraging our platform technology to create a
pipeline of transformational oral biologic therapeutics with unique
and differentiated profiles,” said Tahir Mahmood, Ph.D., chief
executive officer and co-founder of AMT. “Based on our important
preclinical findings to date and similar to our lead program,
AMT-101, an oral IL-10 fusion biologic therapy, AMT-126 has the
potential to be another pipeline in a product for the company
targeting both GI-focused and peripheral diseases. Advancing
AMT-126 into the clinic further validates AMT’s broad oral
biologics technology platform and we look forward to generating
additional pipeline products to address diseases with significant
unmet needs. In addition to this recent progress with AMT-126, the
company remains on track to announce oral AMT-101 top-line data
readouts from the four Phase 2 trials from its comprehensive
clinical program beginning in the second half of this year.”
“Following this Phase 1a single ascending dose
trial, we intend to advance AMT-126 into a Phase 1b trial in
patients who have gastrointestinal barrier dysfunction and expect
the full Phase 1 development plan to resemble our AMT-101
approach,” said Bittoo Kanwar, M.D., chief medical officer of AMT.
“Given the well-established role of IL-22 to promote a healthy
epithelial barrier and regulate inflammation, we see enormous
potential for AMT-126 to address both gastrointestinal disease and
peripheral disease secondary to GI dysfunction. Because AMT-126 is
designed to be gut selective, we believe it may have an improved
safety profile when compared to systemically administered
IL-22.”
About AMT-126
AMT-126 is a novel GI-selective, oral fusion of
hIL-22 and AMT’s proprietary carrier molecule currently in
development for diseases related to intestinal epithelial (IE)
barrier defects. IL-22 is a cytokine that repairs structural and
functional defects of the IE barrier and induces microbial defense.
AMT-126 is designed to act locally on the epithelial cells of the
intestinal tissue, thereby repairing the IE barrier and supporting
mucosal healing.
About AMT-101
AMT-101 is a novel GI-selective, oral fusion of
hIL-10 and AMT’s 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 barrier with limited entry into the
bloodstream, thereby focusing hIL-10 at the primary site of
inflammation for UC and, 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 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 additional oral
biologic product candidates in patient-friendly oral forms that are
designed to either target local gastrointestinal 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 the potential of, potential benefits of, and expectations
regarding AMT’s technology platform and AMT-101 and AMT-126,
statements regarding AMT’s Phase 2 clinical trials for AMT-101
including the timing of such trials, expectations relating to data
readouts from the Phase 2 clinical trials, AMT’s ability to
leverage its technology to expand its pipeline and the timing of
receipt of AMT-126 Phase 1a/b data. 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:Alexandra SantosWheelhouse Life
Science Advisorsasantos@wheelhouselsa.com
Aljanae ReynoldsWheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
Applied Molecular Transp... (NASDAQ:AMTI)
과거 데이터 주식 차트
부터 6월(6) 2024 으로 7월(7) 2024
Applied Molecular Transp... (NASDAQ:AMTI)
과거 데이터 주식 차트
부터 7월(7) 2023 으로 7월(7) 2024