Applied Molecular Transport Completes Enrollment of Phase 2 LOMBARD Monotherapy Trial of Oral AMT-101 in Patients with Moderate-to-Severe Ulcerative Colitis
20 September 2022 - 10:00PM
Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a
clinical-stage biopharmaceutical company, today announced the
company has completed enrollment of the Phase 2 LOMBARD trial for
AMT-101 in 105 patients with moderate-to-severe ulcerative colitis
(UC). AMT-101 is an investigational, once-daily, GI-selective, oral
fusion of IL-10 and AMT’s proprietary carrier molecule.
“Completing enrollment in our LOMBARD trial
marks an important milestone in the ongoing development of oral
AMT-101 as a potential treatment for ulcerative colitis,” said
Bittoo Kanwar, M.D., chief medical officer of AMT. “We look forward
to reporting top-line data, including clinical remission, from the
Phase 2 LOMBARD trial. We would like to thank our patients and
clinical sites around the globe for participating in this
trial.”
About LOMBARDLOMBARD is a Phase
2 double-blinded, placebo-controlled trial that is evaluating the
safety and efficacy of orally administered AMT-101 over 12 weeks in
patients with moderate-to-severe UC. The LOMBARD trial enrolled 105
patients with once-daily dosing to either AMT-101 3mg or placebo.
The global trial enrolled both biologic-experienced and
biologic-naïve patients in 11 countries, including the U.S., Canada
and Europe.
About AMT-101AMT-101 is a novel
GI-selective, oral fusion of IL-10 and AMT’s proprietary carrier
molecule, currently in development in Phase 2 clinical trials for
chronic pouchitis, UC and RA. AMT-101 is designed to cross the
intestinal epithelial (IE) barrier with limited entry into the
bloodstream, thereby focusing IL-10 at the primary site of
inflammation in IBD, along the intestinal tissue lamina propria,
potentially avoiding the side effects observed with systemic
administration.
About Ulcerative ColitisUC is a
chronic inflammatory bowel disease that causes inflammation in the
gastrointestinal (GI) tract. Symptoms may include, but are not
limited to, diarrhea, abdominal pain, bloody stools, rectal
bleeding, weight loss and fatigue. UC affects millions of people
worldwide and may also profoundly impact quality of life. There
remains a significant unmet need for safer and more effective oral
therapies.
About Applied Molecular Transport
Inc.AMT is a clinical-stage biopharmaceutical company
developing novel oral biologic product candidates, by leveraging
its technology platform to design biologic product candidates in
patient friendly oral dosage forms. AMT’s product candidates are
designed to precisely target the relevant pathophysiology of
disease. AMT’s proprietary technology platform is incorporated in
its product candidates, exploiting existing natural cellular
trafficking pathways to drive the active transport of diverse
therapeutic modalities across the IE barrier. Active transport is
an efficient mechanism that utilizes the cell’s own machinery to
transport materials across the IE barrier.
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 as that term is
defined in Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. Such forward-looking
statements involve substantial risks and uncertainties. All
statements other than statements of historical facts contained in
this press release are forward-looking statements including
statements relating to AMT’s plans, expectations, forecasts and
future events. Such forward-looking statements include, but are not
limited to, the potential of, and expectations regarding AMT’s
technology platform, statements regarding AMT-101 including the
potential of AMT-101, the ability of AMT-101 to avoid side effects,
the milestones for AMT-101, AMT-101’s clinical trials including the
timing of top-line results from the Phase 2 LOMBARD monotherapy
trial of AMT-101, the potential market opportunity for AMT-101, the
ability of the Company to advance AMT-101 to future phases of
development, the ability of the Company to obtain regulatory
approval for AMT-101, and statements by AMT’s chief medical
officer. In some cases, you can identify forward-looking statements
by terminology such as “believe,” “estimate,” “intend,” “may,”
“plan,” “potentially,” “will,” “expect,” “enable,” “likely” or the
negative of these terms or other similar expressions. We have based
these forward-looking statements largely on our current
expectations and projections about future events and trends that we
believe may affect our financial condition, results of operations,
business strategy and financial needs. Actual events, trends or
results could differ materially from the plans, intentions and
expectations disclosed in these forward-looking statements based on
various factors. Information regarding the foregoing and additional
risks may be found in the section entitled “Risk Factors” in AMT’s
Annual and Quarterly Reports on Form 10-K and 10-Q filed with the
Securities and Exchange Commission (the “SEC”), 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.
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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