ASLAN Pharmaceuticals Announces Positive Interim Data From the Multiple Ascending Dose Study of ASLAN004 in Atopic Dermatitis...
01 Marzo 2021 - 5:00AM
ASLAN Pharmaceuticals (Nasdaq:ASLN), a clinical-stage immunology
focused biopharmaceutical company developing innovative treatments
to transform the lives of patients, today announced positive
interim unblinded data from the three dose cohorts of its ongoing
randomised, double-blind placebo controlled multiple ascending dose
study of ASLAN004 for the treatment of moderate to severe atopic
dermatitis (AD). ASLAN004 was shown to be well tolerated across all
doses and showed improvements compared to placebo in all efficacy
endpoints, supporting its potential as a differentiated, novel
treatment for AD.
The Phase 1 study evaluated three doses of ASLAN004 (200mg,
400mg and 600mg) delivered subcutaneously and is now recruiting a
fourth (expansion) cohort (600mg). Patients were dosed weekly for
eight weeks to determine the safety and tolerability of ASLAN004 as
well as a number of secondary efficacy outcome measures. The first
three cohorts randomised 25 patients from the United States,
Australia and Singapore. Three patients discontinued study due to
restrictions imposed in response to COVID-19. Of the remaining 22
patients, 18 completed at least 29 days of dosing and assessment
and were evaluable for efficacy.
- The average baseline Eczema Area
Severity Index (EASI) score of patients was 32.5 and the average
Investigators Global Assessment (IGA) score was 3.4 (n=18).
- At week 8, the average reduction in
EASI from baseline at therapeutic doses (400mg and 600mg cohorts)
was 74% (n=9) compared to 42% (n=5) for patients on placebo.
- 89% achieved EASI-50 versus 40% on
placebo;
- 67% achieved EASI-75 versus 0% on
placebo;
- 56% achieved EASI-90 versus 0% on
placebo.
- 22% of patients achieved IGA of 0 or
1 at therapeutic doses versus 0% on placebo.
- Peak pruritus improved after just
one dose and continued to improve by an average of 46% relative to
baseline at 8 weeks compared to 16% for patients on placebo.
- The proportion of patients with
adverse events and treatment-related adverse events were similar
across treatment and placebo arms. There were no treatment-related
adverse events in the active arm that led to discontinuation.
Dr Ken Kobayashi, Chief Medical Officer, ASLAN
Pharmaceuticals, commented: “These data are very
encouraging and provide a strong foundation to confidently advance
our plans for the global Phase 2b study we intend to initiate later
this year. A robust and differentiated safety and efficacy profile
is emerging for ASLAN004 and we look forward to reporting the full,
unblinded data from approximately 50 patients in mid-2021. We
believe the interim data demonstrate ASLAN004’s potential as a
first-in-class therapeutic targeting the IL-13 receptor with a
differentiated approach to treating atopic dermatitis.”
Conference call and webcast
ASLAN’s management will host a webcast and conference call at
8am ET / 9pm SGT today, 1 March 2021, to discuss these interim
data. The live call may be accessed by dialing +1 855 548 1217 for
domestic callers and +1 409 217 8810 for international callers and
entering the conference code: 9199389. A live webcast of the call
will be available using this link:
https://edge.media-server.com/mmc/p/o2mdjnyx. It will also be
available from the News and Events page of the Company’s website at
https://ir.aslanpharma.com/webcasts-presentations and will be
archived there after the live event.
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 Pharmaceuticals
ASLAN 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
potential first-in-class monoclonal therapy, ASLAN004, that is
being developed in atopic dermatitis and other immunology
indications, and ASLAN003, that it plans to develop for autoimmune
disease. For additional information please visit
www.aslanpharma.com.
About ASLAN004
ASLAN004 is a potential first-in-class 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. AD is a chronic, inflammatory
skin condition which severely impacts quality of life for millions
of children and adults globally. ASLAN004 is the only IL-13Rα1
receptor in clinical development for the treatment of AD.
About the study
The data are from the three dose cohorts of 200mg, 400mg and
600mg of ASLAN004 in adults aged 18 or older, with an EASI score of
≥16 and history of inadequate response to a stable (≥1 month)
regimen of topical corticosteroids or calcineurin inhibitors as
treatment for AD within 3 months before the screening visit. The
study is designed to enrol approximately 50 patients and
recruitment into the expansion cohort (600mg) is underway in the
United States, Australia and Singapore.
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, ASLAN004’s potential
as a novel, first-in-class antibody targeting IL-13R with
differentiated efficacy and safety profile in 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
(the “SEC”) filings and reports (Commission File No. 001-38475),
including the Company’s Form 20-F filed with 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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