ASLAN Pharmaceuticals Completes Phase 1 Study for ASLAN004 Targeting Atopic Dermatitis
04 Juni 2019 - 2:00PM
ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage
oncology and immunology focused biopharma company, today
announced the successful completion of its single
ascending dose (SAD) study testing the first-in-class
therapeutic antibody ASLAN004 in healthy volunteers, and the
updated data from the second part of the study that tested a
subcutaneous formulation of ASLAN004. ASLAN004 is a fully human
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 atopic
dermatitis (AD), such as redness and itching of the skin.
Dr Carl Firth, Chief Executive Officer of ASLAN
Pharmaceuticals, said: “The final data from the phase
1 study reaffirms our belief that ASLAN004 has the potential to be
a best-in-class therapy for atopic dermatitis and allows us to
quickly move into a multiple ascending dose study later this year.
We have demonstrated that ASLAN004 has a favourable tolerability
profile when administered either intravenously or subcutaneously
without triggering any serious adverse effects. We believe
ASLAN004’s differentiated profile could offer patients a way to
treat atopic dermatitis with a less frequent dosing-regimen and
more convenient administration relative to existing therapies,
ultimately lowering the burden of AD for patients and healthcare
systems.”
ASLAN reported interim results from the first part of the study,
which tested ASLAN004 administered intravenously, in March 2019.
Data from the second part of the study showed that ASLAN004 was
well tolerated at all doses when administered subcutaneously. There
were no adverse events that led to discontinuations and only one
case of mild itch as an injection site reaction, which resolved
within 24 hours. Analysis of downstream mediators including
phosphorylation of STAT6 (pSTAT6), a critical mediator of
allergic inflammation, demonstrated complete inhibition within one
hour of dosing and a pharmacokinetic profile that suggests ASLAN004
could target a once monthly dose regimen. Notably, it was observed
that the trough level of ASLAN004 required to completely inhibit
signal transduction via the receptor was over an order of magnitude
lower than that of existing therapies.
The positive data follows ASLAN’s announcement on 31 May 2019
that it had amended its agreement with CSL to acquire global rights
to develop, manufacture and commercialise ASLAN004. As a next step,
ASLAN expects to initiate a multiple ascending dose study in
moderate to severe atopic dermatitis patients in the second half of
2019.
Atopic dermatitis is the most common dermatological disease,
affecting over 200 million patients worldwide1, characterized by
red inflamed skin and severe daytime and night-time itching, which
can severely impact patients’ quality of life. Up to one-third of
adult atopic dermatitis patients are considered moderate-to-severe,
for which currently available therapeutics are limited and
management is challenging in the majority of cases.
Media and IR contacts
Emma ThompsonSpurwing CommunicationsTel: +65 6571
2021Email: ASLAN@spurwingcomms.com |
Robert UhlWestwicke PartnersTel: +1 858 356
5932Email: robert.uhl@westwicke.com |
About ASLAN004
ASLAN004 is a fully human monoclonal antibody that targets the
IL-13 receptor α1 subunit, or IL-13Rα1, with potential to be a
best-in-class therapy. By targeting IL-13Rα1, ASLAN004 potently
inhibits signalling of both interleukin 4, or IL-4, and interleukin
13, or IL-13. IL-4 and IL-13 are central to triggering symptoms of
allergy in atopic dermatitis, such as redness and itching of the
skin, as well as asthma symptoms such as shortness of breath,
exacerbations of disease, wheezing and coughing.
About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497) is a
clinical-stage oncology and immunology focused biopharma company
targeting cancers that are both highly prevalent in Asia and orphan
indications in the United States and Europe. Led by a senior
management team with extensive experience in global and regional
development and commercialisation, ASLAN is headquartered in
Singapore and has offices in Taiwan and China. ASLAN’s clinical
portfolio is comprised of three product candidates which target
validated growth pathways applied to new patient segments, novel
immune checkpoints and novel cancer metabolic pathways. ASLAN’s
partners include Array BioPharma, Bristol-Myers Squibb, Almirall
and CSL. 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
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progress and outcome of the Company’s on-going clinical studies,
the Company’s business strategy, the Company’s plans to develop and
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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 US
Securities and Exchange Commission filings and reports (Commission
File No. 001-38475), including the Company’s Annual Report on Form
20-F for the year ended December 31, 2018 filed with the US
Securities and Exchange Commission on April 29,
2019.
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1 Nutten, S. 2015. Atopic dermatitis: global epidemiology and
risk factors
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