Applied Molecular Transport Inc. (NASDAQ: AMTI) today 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 (RA). AMT presented the data in Poster P584Efficacy, 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 (ECCO) ’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 (Tregs) and CD163+ macrophages (M2-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 Bittoo Kanwar M.D., chief medical officer of AMT. “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.
Applied shares shaved off a penny, or 1.5%, to 55 cents.
