Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT) today
announced top-line Phase 2 results from the LOMBARD monotherapy
trial for AMT-101 in biologic-naïve and experienced patients with
moderate-to-severe ulcerative colitis (UC). AMT-101 is an
investigational, once-daily, GI-selective, oral fusion of IL-10 and
AMT’s proprietary carrier molecule. The clinical remission (CR)
rate in patients treated with AMT-101 monotherapy was 17.1% (12/70
patients) compared to a CR rate of 20.0% (7/35 patients) with
placebo, which was above the company’s baseline assumption for
placebo CR rates based on published data in moderate-to-severe UC
patients.
“We thank our patients and sites for
participating in the LOMBARD trial. While we are disappointed with
the top-line results, we are seeking to better understand the
unexpectedly high placebo rate of clinical remission in this
moderate-to-severe population,” said Bittoo Kanwar, M.D., chief
medical officer of AMT. “Separately, we continue to be encouraged
by the positive data generated with AMT-101 in chronic pouchitis,
which has been granted Orphan Drug Designation in this indication.
We will be seeking a partner to advance this program into Phase 3
and look forward to presenting additional pouchitis data at the
European Crohn’s and Colitis Organisation meeting in March
2023.”
Tahir Mahmood, Ph.D., chief executive officer
and co-founder of AMT, added, “Our platform technology has
generated two clinical assets, and we look forward to advancing
AMT-126, an oral fusion of AMT’s proprietary carrier molecule and
IL-22, which is a validated target, into a planned Phase 1b trial
in UC. We remain focused on stepwise execution and will be
judicious in deploying our resources and extending our cash
runway.”
AMT remains focused on developing its two
clinical assets:
- Preparing AMT-126 (oral fusion of
IL-22) for a Phase 1b trial in patients with moderate-to-severely
active UC.
- Exploring a strategic partnership
to advance AMT-101 into Phase 3 in chronic pouchitis and concluding
the ongoing AMT-101 Phase 2 CASTRO combination trial in patients
with rheumatoid arthritis (RA).
LOMBARD ResultsIn the LOMBARD
trial, patients received once-daily oral AMT-101 3mg or placebo in
a 2:1 ratio. The objectives of the LOMBARD trial were to assess the
safety and efficacy of AMT-101 in patients with moderate-to-severe
UC. The key efficacy endpoint of clinical remission was measured at
12 weeks.
Of the 105 patients, 17.1% (12/70) of patients
treated in the monotherapy arm (AMT-101 3mg) achieved clinical
remission versus 20.0% (7/35) in patients receiving placebo at week
12. Clinical remission is defined as Mayo endoscopic subscore of 0
or 1 (blinded central read), rectal bleeding subscore of 0 and
stool frequency subscore of 0 or 1.
AMT-101 was well-tolerated. Treatment emergent
adverse events (TEAEs) were mostly mild to moderate and were
generally balanced between the two arms.
The company plans to present full trial results
at an upcoming medical conference.
About LOMBARDLOMBARD is a Phase
2 double-blinded, placebo-controlled trial that evaluated the
safety and efficacy of orally administered AMT-101 monotherapy over
12 weeks in patients with moderate-to-severe UC. The LOMBARD trial
randomized 105 patients with 12-week once-daily dosing to either
oral AMT-101 3mg or placebo. Safety follow-up is on-going.
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 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-126AMT-126 is a novel
GI-selective, oral fusion of IL-22 and AMT’s proprietary carrier
molecule for diseases related to intestinal epithelial (IE) barrier
defects. IL-22 is a cytokine that repairs structural and functional
defects of the IE barrier and induces microbial defense. AMT-126 is
designed to act locally on the epithelial cells of the intestinal
tissue, thereby repairing the IE barrier and supporting mucosal
healing, potentially translating into clinically meaningful
improvements in a broad range of GI-focused, peripheral
inflammatory and other diseases.
About AMT-101AMT-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, UC and RA. AMT-101 is designed to cross the 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, statements relating to AMT’s cash runway, the potential
of, and expectations regarding AMT’s technology platform,
statements regarding AMT-101 and AMT-126 including the potential of
AMT-101 and AMT-126, the ability of AMT-101 to avoid side effects,
the milestones for AMT-101 and AMT-126, AMT-101 and AMT-126’s
clinical trials and the potential of a partnership to advance
AMT-101, , 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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