ASLAN Pharmaceuticals Initiates Third Dose Cohort of ASLAN004 in Atopic Dermatitis Clinical Trial
October 22 2020 - 7:30AM
ASLAN Pharmaceuticals (Nasdaq:ASLN), a clinical-stage immunology
focused biopharmaceutical company developing innovative treatments
to transform the lives of patients, today announced that the Data
Monitoring Committee (DMC) has completed its planned safety data
review of the second dose cohort of its clinical trial of ASLAN004
in moderate to severe atopic dermatitis (AD) patients. ASLAN004 was
found to be well tolerated at 400mg and the DMC has recommended
that the multiple ascending dose (MAD) clinical study continue as
planned.
ASLAN has now initiated recruitment into the third, highest dose
(600mg) cohort of the randomised, double blind, placebo-controlled
MAD study. A total of eight patients will be recruited from
clinical sites in Singapore, the US and Australia. ASLAN expects to
report interim, unblinded data from all three dose escalation
cohorts in early 2021.
Dr Ken Kobayashi, Chief Medical Officer, ASLAN
Pharmaceuticals, commented: “Importantly,
ASLAN004 continues to be well tolerated in the patients treated in
the study to date and no discontinuations of treatment related to
study drug have been observed. Following the lifting of recruitment
restrictions associated with COVID-19 that had previously delayed
the study, we were pleased to note that the second dose cohort
enrolled all eight patients in around three weeks at two clinical
sites. For the third dose cohort, we will be recruiting patients
from up to nine sites, having activated new sites in Australia and
the US. We believe that ASLAN004 has the potential to be a
best-in-disease treatment for patients with AD and look forward to
reporting further data and firming up our plans to initiate a Phase
2b study in 2021.”
The Phase 1 study is evaluating three doses of ASLAN004 (200mg,
400mg and 600mg) delivered subcutaneously and will include a fourth
(expansion) cohort. Each dose cohort contains up to six patients on
ASLAN004 and two patients on placebo, and the expansion cohort will
contain at least 12 patients on ASLAN004 and at least six patients
on placebo. Patients are dosed weekly for eight weeks to determine
safety and tolerability as well as a number of secondary efficacy
outcome measures.
ASLAN004 is a first-in-class monoclonal antibody that binds to
the IL-13 receptor α1 subunit (IL-13Rα1), blocking signalling of
two pro-inflammatory cytokines, IL-4 and IL-13, which are central
to triggering symptoms of AD, such as redness and itching of the
skin.
Media and IR
contacts
Emma
ThompsonSpurwing CommunicationsTel: +65 6751 2021Email:
ASLAN@spurwingcomms.com |
Robert
UhlWestwicke PartnersTel: +1 858 356 5932 Email:
robert.uhl@westwicke.com |
About ASLAN PharmaceuticalsASLAN
Pharmaceuticals (Nasdaq:ASLN) is a clinical-stage immunology
focused biopharmaceutical company developing innovative treatments
to transform the lives of patients. Led by a senior management team
with extensive experience in global development and
commercialisation, ASLAN has a clinical portfolio comprised of a
first-in-class monoclonal therapy, ASLAN004, that is being
developed in atopic dermatitis and other immunology indications,
and ASLAN003, which it plans to develop for autoimmune disease. For
additional information please visit www.aslanpharma.com.
Forward
looking
statements
This release contains forward-looking statements. These
statements are based on the current beliefs and expectations of the
management of ASLAN Pharmaceuticals Limited and/or its affiliates
(the "Company"). These forward-looking statements may include, but
are not limited to, statements regarding the Company’s business
strategy, the Company’s plans to develop and commercialise
ASLAN004, the safety and efficacy of ASLAN004, the potential for
ASLAN004 to deliver a best-in-disease treatment for people with
atopic dermatitis, and the Company’s plans and expected timing with
respect to enrolment in its clinical trials for ASLAN004 and
clinical trial results for ASLAN004. The Company’s estimates,
projections and other forward-looking statements are based on
management's current assumptions and expectations of future events
and trends, which affect or may affect the Company’s business,
strategy, operations or financial performance, and inherently
involve significant known and unknown risks and uncertainties.
Actual results and the timing of events could differ materially
from those anticipated in such forward-looking statements as a
result of these risks and uncertainties, which include, without
limitation the risk factors described in the Company’s U.S.
Securities and Exchange Commission filings and reports (Commission
File No. 001-38475), including the Company’s Form 20-F filed with
the U.S. Securities and Exchange Commission (the “SEC”) on April
16, 2020.
All statements other than statements of historical fact are
forward-looking statements. The words “believe,” “may,” “might,”
“could,” “will,” “aim,” “estimate,” “continue,” “anticipate,”
“intend,” “expect,” “plan,” or the negative of those terms, and
similar expressions that convey uncertainty of future events or
outcomes are intended to identify estimates, projections and other
forward-looking statements. Estimates, projections and other
forward-looking statements speak only as of the date they were
made, and, except to the extent required by law, the Company
undertakes no obligation to update or review any estimate,
projection or forward-looking statement.
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