New positive data demonstrate oral AMT-101’s gut-restricted profile with tissue-level pharmacodynamics (PD) effects and no systemic exposure by design
Translational analysis reveals IL-10 biological responses in both 3mg and 10mg dose arms
SOUTH SAN FRANCISCO, Calif., March 03, 2023 (GLOBE NEWSWIRE) -- Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT) 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 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 (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.
“These data further support advancement of once daily, oral AMT-101 for chronic pouchitis,” added Tahir Mahmood, Ph.D., chief executive officer and co-founder of AMT. “We remain focused on exploring a strategic partnership for this program and look forward to providing updates in the future.”
FILLMORE is a Phase 2 double-blinded trial that 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. The trial was conducted across 33 sites and 11 countries in patients with daily stool frequency ≥ 6 (and > 3 stools per day more than baseline), Modified Pouchitis Disease Activity Index (mPDAI) score ≥ 5, and histological evidence of pouchitis (Geboes ≥ 3.1), among other entry criteria. Patients must have failed at least one round of antibiotic therapy and no lead-in or rescue antibiotic therapy was allowed.
Approximately 30% of patients with UC eventually require total colectomy. Ileal pouch-anal anastomosis (IPAA) is the surgical treatment of choice as it avoids permanent ileostomy and is associated with better quality of life outcomes. Up to 60,000 patients in the U.S. alone experience pouchitis, inflammation in the lining of the pouch, after IPAA surgery. Acute pouchitis often responds to antibiotic treatment but up to 50% of pouchitis patients develop chronic pouchitis where patients often relapse on or do not respond to antibiotic therapy. Pouchitis is characterized by clinical symptoms of excessive stool frequency, urgency, fecal incontinence, nocturnal seepage and lower abdominal pain. Pouchitis is an orphan indication with no current FDA-approved products.
AMT-101 is a novel GI-selective, oral fusion of IL-10 and AMT’s proprietary carrier molecule, currently in development in Phase 2 clinical trials for chronic pouchitis and RA. AMT-101 is designed to cross the intestinal epithelial (IE) barrier with limited entry into the bloodstream, thereby focusing IL-10 at the primary site of inflammation in IBD, along the intestinal tissue lamina propria, potentially avoiding the side effects observed with systemic administration. U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for AMT-101 in patients with pouchitis.
About Applied Molecular Transport Inc.
AMT is a clinical-stage biopharmaceutical company developing novel oral biologic product candidates, by leveraging its technology platform to design biologic product candidates in patient friendly oral dosage forms. AMT’s product candidates are designed to precisely target the relevant pathophysiology of disease. AMT’s proprietary technology platform is incorporated in its product candidates, exploiting existing natural cellular trafficking pathways to drive the active transport of diverse therapeutic modalities across the IE barrier. Active transport is an efficient mechanism that utilizes the cell’s own machinery to transport materials across the IE barrier.
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 as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements including statements relating to AMT’s plans and prospects, expectations, forecasts and future events. Such forward-looking statements include, but are not limited to, the potential of, and expectations regarding AMT’s technology platform, statements regarding the potential of AMT-101 or regarding AMT-101 clinical trials, statements regarding advancing product candidates to future phases of development, our ability to obtain regulatory approval for AMT’s product candidates, and program updates, the potential for strategic partnerships and other strategic transactions, milestones for AMT’s clinical trials, including potentially advancing AMT-101 for chronic pouchitis, and AMT’s ability to replicate past clinical development strategies, statements regarding the potential for AMT’s product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, statements regarding the mechanism of action of AMT’s product candidates and the potential to avoid side effects with our product candidates, statements regarding the market opportunity for AMT’s product candidates, including the potential pouchitis market and statements by AMT’s chief medical officer and chief executive officer and co-founder. In some cases, you can identify forward-looking statements by terminology such as “believe,” “estimate,” “intend,” “may,” “plan,” “potentially,” “will,” “expect,” “enable,” “likely” or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual events, trends or results could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements based on various factors. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in AMT’s Annual and Quarterly Reports on Form 10-K and 10-Q filed with the Securities and Exchange Commission (the “SEC”), and AMT’s future reports to be filed with the SEC. 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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