Applied Molecular Transport Completes Enrollment of Phase 2 LOMBARD Monotherapy Trial of Oral AMT-101 in Patients with Moderate-to-Severe Ulcerative Colitis
Applied Molecular Transport Inc. (NASDAQ: AMTI) announced the completion of enrollment for its Phase 2 LOMBARD trial of AMT-101, aimed at treating moderate-to-severe ulcerative colitis (UC). The trial enrolled 105 patients globally and is designed to evaluate the drug's safety and efficacy over 12 weeks. Top-line data, including clinical remission rates, is expected to be reported in late 2022 or early 2023. AMT-101, a novel oral fusion of IL-10, aims to target inflammation directly in the gastrointestinal tract while minimizing systemic side effects.
- Successful completion of enrollment for the Phase 2 LOMBARD trial involving 105 patients.
- Anticipation of top-line data to be reported in late 2022 or early 2023, which could impact future development.
- None.
Top-line data readout anticipated late 2022 or early 2023
SOUTH SAN FRANCISCO, Calif., Sept. 20, 2022 (GLOBE NEWSWIRE) -- 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 LOMBARD
LOMBARD 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-101
AMT-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 Colitis
UC 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 Statements
This 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 Chang
Head, Investor Relations & Corporate Communications
achang@appliedmt.com
Media Contacts:
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Wheelhouse Life Science Advisors
asantos@wheelhouselsa.com
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com
FAQ
What is the purpose of the Phase 2 LOMBARD trial for AMT-101?
When will the top-line data from the LOMBARD trial be available?
How many patients were enrolled in the LOMBARD trial for AMT-101?
What are the expected outcomes measured in the LOMBARD trial?
What is AMT-101 and how does it work?
