Applied Molecular Transport Presents Additional Data from Oral AMT-101 Phase 2 FILLMORE Trial in Chronic Pouchitis at ECCO ’23 Congress
2023年3月3日 - 10:00PM
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.”
About FILLMORE
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.
About Pouchitis
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.
About AMT-101
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.
Forward-Looking Statements
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.
Investor Relations Contact:Andrew ChangHead,
Investor Relations & Corporate
Communicationsachang@appliedmt.com
Media Contacts:Alexandra SantosWheelhouse Life
Science Advisorsasantos@wheelhouselsa.com
Aljanae ReynoldsWheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
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