Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT) today
announced positive top-line Phase 2 results from the FILLMORE
monotherapy trial for AMT-101 in patients with chronic pouchitis,
an orphan indication with significant unmet medical need and no
current FDA-approved therapies. 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 ulcerative colitis (UC) and rheumatoid arthritis (RA).
FILLMORE ResultsThe objectives of the FILLMORE
trial were to assess the safety and efficacy of AMT-101 in severe
chronic pouchitis patients and to select a dose for Phase 3. The
trial was designed to measure two key pre-specified efficacy
endpoints: 1) symptomatic improvement, as measured by stool
frequency response, and 2) histologic healing, as measured by
central read.
On the first measure, results from the trial
demonstrated that 36.4% (8/22) of patients achieved stool frequency
response, defined as a reduction of ≥ 3 stools and ≥ 30% from
baseline, OR ≤ post-colectomy normal. Rapid onset of stool
frequency response was demonstrated as early as week 2 in both
dosage groups and was maintained through the duration of treatment.
Top-line interim data demonstrated additional symptomatic
improvements in fecal urgency, incontinence and abdominal cramps.
The proportion of patients achieving the symptomatic stool
frequency response in both dosage groups exceeded the criteria for
determining advancement into Phase 3.
On the second measure, 22.7% (5/22) of patients
met the pre-specified histologic healing response of Geboes score ≤
3.1, an objective assessment of disease improvement. FILLMORE
patients had a median baseline Geboes score of 5.1, representing
severe pouchitis with ulceration and tissue destruction. Both
dosage groups demonstrated histologic healing response. Top-line
endoscopic assessments, which may be less relevant in chronic
pouchitis than in other IBD indications, were also performed, with
modest directional improvements. Histology and endoscopy data were
centrally read.
|
|
n(%) Patients Achieving Response |
Pre-specified Efficacy Endpoint |
Endpoint Definition |
3 mg (N=10) |
AMT-101 10 mg (N=12) |
Total (N=22) |
Stool Frequency Response (%) at Week 12 |
Reduction of ≥ 3 stools and ≥ 30% from baseline,
OR ≤ post-colectomy normal |
4(40.0%) |
4(33.3%) |
8(36.4%) |
Histologic Healing Response (%) at Week 12 |
Geboes score ≤ 3.1 |
2(20.0%) |
3(25.0%) |
5(22.7%) |
AMT-101 appeared safe and well-tolerated.
Treatment emergent adverse events (TEAEs) were mostly mild to
moderate, with only one serious adverse event (SAE) observed,
cytomegalovirus (CMV) infection, which was determined to be
unrelated to study drug.
The FILLMORE independent DMC recommends
advancing AMT-101 to Phase 3 with the 3mg dose in chronic
pouchitis, based on its review of safety and efficacy data
available to date. The DMC was comprised of leading experts from
Yale University, Harvard University and its associated medical
institutions.
The Company plans to present full trial results
at an upcoming medical conference.
“The results of the FILLMORE Phase 2 trial are
compelling and demonstrate the activity of orally administered
AMT-101 in chronic pouchitis,” said Brian Feagan, M.D., Professor
of Medicine, Departments of Medicine, Division of Gastroenterology,
Epidemiology and Biostatistics at Western University, Canada.
“These data are impressive given that the patient population
enrolled in the trial had advanced disease, with severe symptoms
that negatively impact their quality of life. These data not only
demonstrated objective histologic healing, but more importantly
showed a rapid reduction in daily stool frequency and improvement
in urgency, incontinence and abdominal cramps, key measures that
are most important to patients and clinicians.”
“Given the severity of the disease and positive
top-line results of the trial, we are excited to share these data
with FDA and other regulatory agencies to advance AMT-101
development in chronic pouchitis,” said Bittoo Kanwar, M.D., chief
medical officer of AMT. “We believe these data support the
therapeutic potential of AMT-101 to treat diseases associated with
mucosal immunology and inflammation. We thank our patients and
sites for participating in the trial.”
AMT anticipates top-line results from its
additional Phase 2 trials investigating oral AMT-101 as follows:
the MARKET trial in combination with anti-TNFα for UC in the second
quarter of 2022, the LOMBARD trial as a monotherapy for UC in the
second half of 2022 and the CASTRO trial in combination with
anti-TNFα for RA in the second half of 2022.
Conference Call & Webcast InformationAMT
will host an investor conference call and live webcast today, April
25, 2022, at 8:30 a.m. ET (5:30 a.m. PT) to discuss the FILLMORE
Phase 2 trial results.
When: April 25, 2022, 8:30 a.m. ET (5:30 a.m. PT)Dial-in: (844)
422-9742 (United States) or (706) 758-6032
(International)Conference ID: 5649019
Please join the conference call or webcast approximately 15
minutes early to register. The live webcast will be accessible via
the Events page of the Applied Molecular Transport website at
https://ir.appliedmt.com/news-events/events. An archived replay
will be available for 30 days following the event.
About FILLMOREFILLMORE 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 PouchitisApproximately
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 therapies.
About AMT-101AMT-101 is a novel
GI-selective, oral fusion of IL-10 and AMT’s proprietary carrier
molecule, currently in development in four Phase 2 clinical trials
for chronic pouchitis, UC 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.
About Applied Molecular Transport
Inc.AMT 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 IE barrier.
Active transport is an efficient mechanism that uses the cell’s own
machinery to transport materials across the IE barrier. AMT is
developing additional oral biologic product candidates in
patient-friendly oral dosage forms that are designed to either
target local intestinal tissue or enter systemic circulation to
precisely address the relevant pathophysiology of 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
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, 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 scaling our organization,
growth of clinical activities, or pipeline expansion, statements
regarding the optimization or expansion of our product development
plans or the design of future clinical trials, statements regarding
the potential of AMT-101 or regarding AMT-101 clinical trials,
including the timing of data readouts from such trials including
top-line results from the MARKET trial in combination with
anti-TNFα for UC, the LOMBARD trial as a monotherapy for UC and the
CASTRO trial in combination with anti-TNFα for RA, statements
regarding the market potential of AMT’s product candidates,
advancing product candidates to future phases of development,
statements regarding our ability to obtain regulatory approval for
AMT’s product candidates, and program updates, milestones for such
trials, and our 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, assumptions regarding the
mechanism of action of our product candidates and the potential to
avoid side effects with our product candidates, statements
regarding the market opportunity for our product candidates and
statements by AMT’s chief medical officer. 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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