Applied Molecular Transport presents additional data from FILLMORE trial

Applied Molecular Transport announced additional Phase 2 data for oral AMT-101 in chronic pouchitis patients. AMT-101 is an investigational, once-daily, GI-selective, oral fusion of IL-10 and AMT’s proprietary carrier molecule, which is also in development for the treatment of rheumatoid arthritis. AMT presented the data in Poster P584 Efficacy, Safety, and Tolerability of AMT-101: A Gut Selective Oral IL-10 Fusion in the Phase 2 FILLMORE Trial of Patients with Chronic Pouchitis at the European Crohn’s and Colitis Organisation ’23 Congress. "We are pleased to share these important new findings from the FILLMORE Phase 2 trial in patients with chronic pouchitis. We observed AMT-101’s immunomodulatory effect with enrichment of tissue FOXP3+ regulatory T cells and CD163+ macrophages within the lamina propria. Tissue levels of IL-10 were also increased with both the 3mg and 10mg doses providing evidence of active transport," said CMO Bittoo Kanwar. "These insights further build on earlier positive top-line results demonstrating AMT-101’s safety profile and clinically meaningful responses in stool frequency and histologic healing in this severe patient population." The FILLMORE Phase 2 double-blinded trial evaluated the safety and efficacy of orally administered AMT-101 monotherapy, over 12 weeks, in patients with chronic pouchitis. The FILLMORE trial randomized 22 patients to 3mg or 10mg of oral AMT-101.