Applied Molecular Transport Inc. 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. 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. 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. 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.