Applied Molecular Transport Presents Additional Positive Data from Oral AMT-101 Phase 1b in Ulcerative Colitis at ECCO '21 Virtual Congress
Once daily, oral AMT-101 was safe and well tolerated, and demonstrated trends of improvement in objective measures of inflammation: fecal calprotectin, CRP, and histology
Key findings support oral AMT-101 actively exerts immunomodulatory effect resulting in local and systemic benefit
Microbiome analyses demonstrate enhancement of favorable enteric commensal bacteria, correlated with restoration of intestinal immune homeostasis
Company on track to announce oral AMT-101 top-line data readouts from the four Phase 2 trials, being conducted in multiple ulcerative colitis populations and rheumatoid arthritis, beginning in the second half of 2021 and into 2022
SOUTH SAN FRANCISCO, Calif., July 09, 2021 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a clinical-stage biopharmaceutical company, today announced additional Phase 1b data for oral AMT-101 in ulcerative colitis (UC) patients. AMT-101 is a novel GI-selective, oral fusion of hIL-10 and AMT’s proprietary carrier molecule. AMT presented the data in ePoster P294 AMT-101, a gut selective oral IL-10 fusion: results from a Phase 1b study in patients with active Ulcerative Colitis at the European Crohn’s and Colitis Organisation (ECCO) ‘21 Virtual Congress.
“Today’s presentation highlighted important findings that support the use of once daily, oral AMT-101 in patients with active UC. We observed AMT-101 actively exerting an immunomodulatory effect by targeting lamina propria immune cells resulting in both local and systemic benefit,” said Stefan Schreiber, M.D., University Hospital Schleswig-Holstein, Dep. Medicine, Kiel, Germany. “After only 14 days of treatment, potential clinical efficacy was observed at doses of 10mg or less with a reduction in average CRP and fecal calprotectin levels, enhancement of favorable enteric commensal bacteria and histological improvements in patients. Additionally, oral AMT-101 was safe and well tolerated without any AEs previously observed with systemic IL-10. As expected, with this gut-selective therapy, no systemic PK was detected.”
The Phase 1b multiple ascending dose trial evaluated safety and was a randomized, placebo-controlled 3:1, double-blind trial that included 16 patients with active ulcerative colitis. Patients received a 14-day treatment period of oral AMT-101 at 1, 3, 10, and 30mg doses.
“These data further support advancement into our comprehensive Phase 2 development plan to explore oral AMT-101 in lnger durations studies, for both IBD and RA,” added Bittoo Kanwar M.D., chief medical officer. “As a result of the compelling Phase 1b findings presented today, we have strategically designed four global trials to potentially provide patients the greatest benefit and to generate data in monotherapy and combination regimens in both biologic-naïve and -experienced patient settings. We look forward to sharing topline data readouts for the four Phase 2 studies beginning in the second half of this year.”
About Applied Molecular Transport Inc.
AMT’s headquarters, internal GMP manufacturing and lab facilities are located in South San Francisco, CA. For additional information on AMT, please visit www.appliedmt.com.
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