ASLAN Pharmaceuticals Completes First Part of Single Ascending Dose Study for ASLAN004 Targeting Atopic Dermatitis
29 März 2019 - 10:50AM
ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage
biopharmaceutical company developing novel therapeutics for global
markets, today announced the completion of the first part
of the single ascending dose (SAD) study testing the
intravenous formulation of the first-in-class therapeutic antibody
ASLAN004 in healthy volunteers. 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, such as redness and itching of the skin.
The phase 1 SAD study was conducted at a single site in
Singapore and demonstrated that ASLAN004 was safe and well
tolerated at all doses when administered to healthy volunteers
intravenously. There were no adverse events that led to
discontinuations. Analysis of downstream mediators including
phosphorylation of STAT6 (pSTAT6), a critical mediator of
allergic inflammation, demonstrated complete inhibition within one
hour of dosing, which was then maintained for more than 29 days,
suggesting monthly dosing may be achievable.
In the second part of the ongoing SAD study, a subcutaneous
formulation is being tested. ASLAN dosed the last patient on 27
March and will report data from the second part of the study in
May. ASLAN plans to initiate a multiple ascending dose study in
moderate to severe atopic dermatitis patients in the second half of
2019.
Dr Mark McHale, Head of Research & Development of
ASLAN Pharmaceuticals, said: “ASLAN is the
only company with a therapeutic antibody
targeting IL-13Rα1, and ASLAN004 is only the second drug after
dupilumab to target the receptor complex, blocking signalling of
both IL-4 and IL-13. Targeting this receptor complex has been shown
to be highly effective in atopic dermatitis and, in contrast to
ligand blockade, has also been successful in other allergic disease
indications, such as asthma. Although there are several drugs in
development for atopic dermatitis, no-one has yet demonstrated
once-monthly dosing with efficacy comparable or superior to
dupilumab.”
Atopic dermatitis (AD) is the most common dermatological
disease, affecting over 200 million patients worldwide1,
characterised by red inflamed skin and severe daytime and night
time itching, which can severely impact patients’ quality of
life. In the US, it is estimated that AD occurs in 7.3% of adults2
whilst the global atopic dermatitis market is estimated to reach
US$14.8 billion by 20253. Currently available therapeutics are
limited and management is challenging in the majority of cases.
Media and IR contacts
Emma
ThompsonSpurwing CommunicationsTel: +65 6340 7287Email:
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,
wheezing and coughing.
About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497) is a
clinical-stage oncology-focused biopharmaceutical company
developing novel therapeutics for global markets. ASLAN targets
diseases 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 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 statementsThis release and the
accompanying financial information, if any, contains
forward-looking statements. These statements are based on the
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Pharmaceuticals Limited and/or its affiliates (the "Company").
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___________________________________1 Nutten, S. 2015. Atopic
dermatitis: global epidemiology and risk factors2 Atopic Dermatitis
in America, accessed 17 October 20183 Decision Resources, 2017
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