ASLAN Pharmaceuticals Initiates Third Dose Cohort of ASLAN004 in Atopic Dermatitis Clinical Trial





ASLAN


has initiated recruitment of patients


into


third


dos


e


cohort


at


sites in


the


US, Australia and Singapore


following successful safety review of second cohort





ASLAN004 found to be well tolerated


at 400mg dose


, third cohort will test 600mg dose

SINGAPORE, Oct. 22, 2020 (GLOBE NEWSWIRE) — 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 t


he 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.


M


edia


and IR


contacts


Emma Thompson


Spurwing Communications

Tel: +65 6751 2021

Email:

[email protected]


Robert


Uhl


Westwicke Partners

Tel: +1 858 356 5932

Email:

[email protected]


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 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


l


ooking


s


tatements

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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