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Friday, March 29, 2019

Aslan Pharmaceuticals completes first part of ASLAN004 study

Aslan Pharmaceuticals announced the completion of the first part of the single ascending dose, or SAD, study testing the intravenous formulation of the therapeutic antibody ASLAN004 in healthy volunteers. ASLAN004 is a fully human monoclonal antibody that binds to the IL-13 receptor a1 subunit, or IL-13Ra1, 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, a 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 March 27 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 the year.

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