Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT) today
announced top-line Phase 2 results from the MARKET combination
trial for AMT-101 in biologic-naïve patients with
moderate-to-severe UC. AMT-101 is an investigational, once-daily,
GI-selective, oral fusion of IL-10 and AMT’s proprietary carrier
molecule.
MARKET ResultsIn the MARKET
trial, patients received either once-daily oral AMT-101 3mg in
combination with adalimumab (sub-cutaneous administration per the
approved UC label), or adalimumab alone (with placebo). The
objectives of the MARKET trial were to assess the safety and
efficacy of AMT-101 in combination with anti-TNFα therapy
(adalimumab) in patients with moderate-to-severe UC. The key
efficacy endpoint of clinical remission was measured at 8
weeks.
The clinical remission rate in the adalimumab
alone arm was higher than historical anti-TNFα monotherapy
benchmarks, and the data from the MARKET trial did not demonstrate
added clinical benefit in the combination arm compared to the
adalimumab alone arm at week 8. Of the 49 evaluable patients, 31.8%
(7/22) of patients treated in the combination arm (AMT-101 3mg with
adalimumab) achieved clinical remission versus 33.3% (9/27) in
patients receiving adalimumab alone at week 8. Clinical remission
is defined as Mayo endoscopic subscore of 0 or 1, rectal bleeding
subscore of 0 and stool frequency subscore of 0 or 1.
AMT-101 appeared safe and well-tolerated.
Treatment emergent adverse events (TEAEs) were mostly mild to
moderate, with one serious adverse event (SAE) observed, worsening
of UC, which was determined to be unrelated to study treatment.
Overall patient demographics were balanced
between the two arms with the exception of patients in the
combination arm having much shorter duration of UC history versus
patients in adalimumab alone arm. Based on this observation, we
conducted a post hoc sub-group analysis to explore the potential
effect of duration of UC history on clinical remission.
Sub-group analysis revealed that patients with a
shorter duration of UC (< 5 years) had clinical remission rates
of 43.8% (7/16) in the combination arm versus 15.4% (2/13) in the
adalimumab alone arm. In patients with longer duration UC (≥ 5
years), clinical remission rates were 0.0% (0/6) in the combination
arm versus 50.0% (7/14) in patients receiving adalimumab alone.
These data suggest that combination treatment
with AMT-101 earlier in the course of UC may be more beneficial
than anti-TNFα alone within 5 years of diagnosis. Further
evaluation and analyses are ongoing.
|
n (%) Patients |
Clinical Remission*(at week
8) |
AMT-101 3mg
with adalimumab |
Placebo withadalimumab |
Overall |
7/22 (31.8%) |
9/27 (33.3%) |
Patients with UC < 5 years |
7/16 (43.8%) |
2/13 (15.4%) |
Patients with UC ≥ 5 years |
0/6 (0.0%) |
7/14 (50.0%) |
* Mayo endoscopic subscore of 0 or 1 (blinded
central read), rectal bleeding subscore of 0 and stool frequency
subscore of 0 or 1
The Company plans to present full trial results
at an upcoming medical conference.
“While the clinical remission rates for
combination therapy surpassed previous anti-TNFα monotherapy and UC
clinical remission benchmarks, we did not anticipate the high rate
of remission in the adalimumab alone arm. The observation of an
unequal duration of UC between the trial arms led us to perform a
post hoc sub-group analysis which supports additive efficacy with
the combination in patients earlier in their course of UC. These
data will further inform our future development plans for AMT-101
in combination therapy and we plan to discuss next steps with FDA.
I am pleased by the growing body of data supporting clinical
efficacy of AMT-101 as a monotherapy as well as in combination
therapy,” said Bittoo Kanwar, M.D., chief medical officer of AMT.
“We thank our patients and sites for participating in the MARKET
trial.”
“As a gastroenterologist specializing in IBD, I
am encouraged by the results of this trial that suggest that
earlier treatment with AMT-101 combination therapy may have an
additive benefit to patients with UC. This supports previously
reported data by our laboratory highlighting the potential for
combination therapy with IL-10 in IBD,” said Geert D'Haens, M.D.,
Ph.D., Professor of Medicine and Gastroenterology at the Academic
Medical Centre, University of Amsterdam. Dr. D’Haens is co-founder
of the European Crohn’s and Colitis Organization (ECCO) and Lead
Principal Investigator of the MARKET trial.
AMT anticipates a number of milestones for its
AMT-101 development program in IBD. For chronic pouchitis, FDA has
granted an end of Phase 2 meeting for AMT-101 to discuss Phase 3
development. The company also anticipates top-line results from its
ongoing AMT-101 Phase 2 LOMBARD monotherapy trial for UC in the
second half of 2022.
Conference Call & Webcast InformationAMT
will host a live investor conference call and webcast today, July
6, 2022, at 8:30 a.m. ET (5:30 a.m. PT).
To join the conference call via phone and
participate in the live Q&A session, please pre-register online
here to receive a telephone number and unique passcode required to
enter the call. A live webcast will be available on 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 MARKETMARKET is a Phase 2
double-blinded, placebo-controlled trial that evaluated the safety
and efficacy of orally administered AMT-101 in combination with
anti-TNFα (adalimumab) over 8 weeks in patients with
moderate-to-severe UC. The MARKET trial randomized 51 patients with
8-week once-daily dosing to either oral AMT-101 3mg and adalimumab
or adalimumab alone (plus placebo).
About Ulcerative ColitisUC is a
chronic inflammatory bowel disease that causes inflammation in the
gastrointestinal (GI) tract. Symptoms may include, but are not
limited to, diarrhea, abdominal pain, bloody stools, rectal
bleeding, weight loss and fatigue. UC affects millions of people
worldwide and may also profoundly impact quality of life. There
remains a significant unmet need for safer and more effective oral
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
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 StatementsThis
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 AMT-101 including the
potential of AMT-101, the ability of AMT-101 to avoid side effects,
the milestones for AMT-101, AMT-101’s clinical trials including the
timing of top-line results from the AMT-101 Phase 2 trials, the
LOMBARD trial as a monotherapy for UC and the CASTRO trial in
combination with anti-TNFα for, advancing AMT-101 to future phases
of development and statements regarding our ability to obtain
regulatory approval for AMT-101, 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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