ASLAN Pharmaceuticals Enrolls First Patient in Proof-of-Concept Study for ASLAN004 Targeting Atopic Dermatitis
October 22 2019 - 2:45AM
ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage
oncology and immunology focused biopharma company, today
announced the enrolment of the first patient in its multiple
ascending dose (MAD) study testing the first-in-class
therapeutic antibody ASLAN004 in moderate to severe atopic
dermatitis (AD) patients.
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 AD, such as redness and itching of the
skin.
The randomised, double blind, placebo-controlled study will
initially be conducted at Singapore’s National Skin Centre and
Changi General Hospital and will be led by Prof Steven Thng. It is
the second part of a phase 1 study of ASLAN004 and will be
conducted in AD patients. In June 2019 ASLAN announced the
successful completion of the first part of the study, a single
ascending dose (SAD) study that tested ASLAN004 in healthy
volunteers, administered either intravenously or subcutaneously.
The MAD study will evaluate 3 doses of ASLAN004 delivered
subcutaneously and will be followed by an expansion cohort at the
most efficacious dose. The study will recruit up to 50 moderate to
severe AD patients and results are expected in the second half of
2020.
Dr Carl Firth, Chief Executive Officer of ASLAN
Pharmaceuticals, said: “Atopic dermatitis continues
to be a high burden, high morbidity inflammatory skin condition but
our recent clinical studies have demonstrated ASLAN004’s
differentiated profile and potential as a best-in-class therapy
that could offer patients greater convenience via less frequent
dosing and a favourable tolerability profile. AD is a key research
area for the team at the National Skin Centre and we look forward
to working closely with Prof Thng and his colleagues to conduct the
MAD study.”
In June 2019, ASLAN presented data from the SAD study that
showed ASLAN004 was well tolerated at all doses and 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 and a
pharmacokinetic profile that suggested ASLAN004 could potentially
target a once monthly dosing regimen. Notably, it was observed that
the predicted 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.
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 (IL-13Rα1) with potential to be a
best-in-class therapy. By targeting IL-13Rα1, ASLAN004 potently
inhibits signalling of the cytokines interleukin 4 (IL-4) and
interleukin 13 (IL-13). IL-4 and IL-13 are central to
triggering symptoms of allergy in atopic dermatitis, such as
redness, drying and excessive itching of the skin. In
allergic asthma these cytokines trigger symptoms such as fibrosis,
weakening of tight junctions, vascular leakage, 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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