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 longer 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.”
AMT-101 is a novel GI-selective, oral fusion of hIL-10 and AMT’s proprietary carrier molecule, and is currently being developed in four Phase 2 clinical trials in inflammatory bowel diseases and rheumatoid arthritis. AMT-101 is designed to cross the intestinal epithelial (IE) barrier with limited entry into the bloodstream, thereby focusing hIL-10 at the primary site of inflammation for UC and potentially avoiding the side effects observed with systemic administration. By design, AMT-101 is actively transported through the IE barrier into the GI tissue, the primary site of inflammation in UC.
About Applied Molecular Transport Inc.
Applied Molecular Transport Inc. is a clinical-stage biopharmaceutical company leveraging its proprietary technology platform to design and develop a pipeline of novel oral biologic product candidates to treat autoimmune, inflammatory, metabolic, and other diseases. AMT’s proprietary technology platform allows it to exploit existing natural cellular trafficking pathways to facilitate the active transport of diverse therapeutic modalities across the intestinal epithelial (IE) barrier. Active transport is an efficient mechanism that uses the cell’s own machinery to transport materials across the IE barrier. AMT believes that its ability to exploit this mechanism is a key differentiator of its approach. AMT is developing additional oral biologic product candidates in patient-friendly oral forms that are designed to either target local intestinal tissue or enter systemic circulation to precisely address the relevant biology of a disease.
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.
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or AMT’s future plans, strategy and performance. Such statements include, but are not limited to, the potential of, and expectations regarding the potential of, potential benefits of, and expectations regarding AMT’s technology platform and AMT-101, statements regarding AMT’s Phase 2 clinical trials for AMT-101 including the timing of such trials, expectations relating to data readouts from the Phase 2 clinical trials, and AMT’s ability to leverage its technology to expand its pipeline. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including those more fully described under the section entitled “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and AMT assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.
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