Applied Molecular Transport Expands Clinical Pipeline and Announces First Subject Dosed in Phase 1a Trial of Oral AMT-126

Company expands pipeline with second clinical program, AMT-126, an oral IL-22 fusion biologic therapy for diseases associated with intestinal epithelial barrier defects

IL-22 deficiency implicated in broad range of gastrointestinal-focused and peripheral diseases ranging from ulcerative colitis to multiple rheumatologic disorders

Complete oral AMT-126 Phase 1a/b data in healthy volunteers and patients anticipated in 2022

Company 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 2021

SOUTH SAN FRANCISCO, CA, USA I March 01, 2021 I 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

SOURCE: Applied Molecular Transport

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