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AMT-101 is a novel, investigational, GI-selective, oral recombinant fusion protein composed of human interleukin-10 (IL-10) and a proprietary carrier molecule. It is designed to cross the intestinal epithelial barrier with limited systemic exposure, thereby concentrating IL-10 at sites of inflammation in the gastrointestinal tract. The drug aims to induce anti-inflammatory effects locally by acting on macrophages and lymphocytes within intestinal tissue. AMT-101 was developed for inflammatory bowel diseases such as ulcerative colitis and pouchitis, as well as rheumatoid arthritis. It received FDA Orphan Drug Designation for pouchitis but its development has been suspended in all indications after phase 2 trials[1][2][4][5][6].
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