Applied Molecular Transport Announces First Patient Dosed in Phase 2 Study of Oral AMT-101 in Ulcerative Colitis

Rhea-AI Summary

Applied Molecular Transport (Nasdaq: AMTI) announced the initiation of a Phase 2a clinical trial for AMT-101, an oral biologic aimed at treating moderate to severely active ulcerative colitis (UC). The trial, which will involve around 100 adult patients across 20 countries, is designed to assess the efficacy and safety of AMT-101 versus placebo over 12 weeks. AMT-101 uniquely targets the gastrointestinal tract, potentially minimizing systemic side effects. The company is optimistic about AMT-101's broader therapeutic applications, planning additional Phase 2 studies for other indications.

Positive

• First patient dosed in Phase 2a study for AMT-101 targeting ulcerative colitis.
• AMT-101 designed to provide localized treatment with reduced systemic side effects.
• Plans to initiate three additional Phase 2 studies to further evaluate AMT-101's potential.

Negative

• None.

SOUTH SAN FRANCISCO, Calif., Aug. 27, 2020 (GLOBE NEWSWIRE) -- 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 Wheeler
Principal, Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com

Alexandra Santos
Senior Partner, Wheelhouse Life Science Advisors
asantos@wheelhouselsa.com

FAQ

What is the purpose of the Phase 2a study for AMT-101?

The Phase 2a study aims to evaluate the efficacy and safety of oral AMT-101 in patients with moderate to severely active ulcerative colitis.

How many patients will be involved in the AMT-101 study?

The study will include approximately 100 adult patients.

What are the key endpoints of the AMT-101 trial?

The primary endpoint is to assess the efficacy of AMT-101 in reducing components of the Mayo Score at week 12, alongside safety and pharmacokinetics.

In which countries will the AMT-101 trial be conducted?

The trial will be conducted in approximately 20 countries globally.

What prior results support the efficacy of AMT-101?

Previous Phase 1b trials demonstrated that oral AMT-101 was safe and improved objective disease markers in ulcerative colitis patients.