Applied Molecular Transport Presents Additional Positive Data from Oral AMT-101 Phase 1b in Ulcerative Colitis at ECCO ‘21 ...
09 7월 2021 - 9:00PM
Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a
clinical-stage biopharmaceutical company, today announced
additional Phase 1b data for oral AMT-101 in ulcerative colitis
(UC) patients. AMT-101 is a novel GI-selective, oral
fusion of hIL-10 and AMT’s proprietary carrier molecule. AMT
presented the data in ePoster P294 AMT-101, a gut selective oral
IL-10 fusion: results from a Phase 1b study in patients with active
Ulcerative Colitis at the European Crohn’s and Colitis Organisation
(ECCO) ‘21 Virtual Congress.
“Today’s presentation highlighted important
findings that support the use of once daily, oral AMT-101 in
patients with active UC. We observed AMT-101 actively exerting an
immunomodulatory effect by targeting lamina propria immune cells
resulting in both local and systemic benefit,” said Stefan
Schreiber, M.D., University Hospital Schleswig-Holstein, Dep.
Medicine, Kiel, Germany. “After only 14 days of treatment,
potential clinical efficacy was observed at doses of 10mg or less
with a reduction in average CRP and fecal calprotectin levels,
enhancement of favorable enteric commensal bacteria and
histological improvements in patients. Additionally, oral AMT-101
was safe and well tolerated without any AEs previously observed
with systemic IL-10. As expected, with this gut-selective therapy,
no systemic PK was detected.”
The Phase 1b multiple ascending dose trial
evaluated safety and was a randomized, placebo-controlled 3:1,
double-blind trial that included 16 patients with active ulcerative
colitis. Patients received a 14-day treatment period of oral
AMT-101 at 1, 3, 10, and 30mg doses.
“These data further support advancement into our
comprehensive Phase 2 development plan to explore oral AMT-101 in
longer durations studies, for both IBD and RA,” added Bittoo Kanwar
M.D., chief medical officer. “As a result of the compelling Phase
1b findings presented today, we have strategically designed four
global trials to potentially provide patients the greatest benefit
and to generate data in monotherapy and combination regimens in
both biologic-naïve and -experienced patient settings. We look
forward to sharing topline data readouts for the four Phase 2
studies beginning in the second half of this year.”
About AMT-101AMT-101 is a novel
GI-selective, oral fusion of hIL-10 and AMT’s proprietary carrier
molecule, and 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 epithelial (IE) 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 epithelial (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 intestinal 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, 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, and AMT’s ability to leverage its
technology to expand its pipeline. 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
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