Aslan Pharmaceuticals reports preliminary data from ASLAN004 study
ASLAN Pharmaceuticals announced positive preliminary data from the lowest dose cohort of its ongoing multiple ascending dose, or MAD, study of ASLAN004 for the treatment of moderate-to-severe atopic dermatitis, or AD. ASLAN004 is a first-in-class fully human monoclonal antibody that binds to the IL-13 receptor alpha1 subunit (IL-13Ralpha1), 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 first patient was enrolled into the double blind study at Changi General Hospital in Singapore on 22 October 2019. As of November 29, 6 patients had been treated in the lowest dose cohort and 3 have completed at least one month of dosing. In a review of unclean blinded data, the Eczema Area and Severity Index, or EASI, scores of the 3 patients were reduced by 85%, 70% and 59% from baseline and the EASI score continued to fall at 4 weeks with maximal efficacy expected at 6 to 8 weeks. ASLAN004 was well-tolerated and, to date, there have been no serious adverse events or treatment discontinuations. Corresponding changes were seen in other measures of efficacy. The data monitoring committee, or DMC, will meet in late December, after which the second dose cohort is expected to open. The randomised, double-blind, placebo-controlled MAD study will evaluate 3 doses of ASLAN004 delivered subcutaneously and will be followed by an expansion cohort at the most efficacious dose. Each dose cohort will contain up to 6 patients on ASLAN004 and 2 patients on placebo, and the expansion cohort will contain 12 patients on ASLAN004 and 6 patients on placebo. Patients are dosed weekly for 8 weeks to determine safety and the maximal efficacy of ASLAN004. The study will recruit up to 50 moderate-to-severe atopic dermatitis patients and study completion is expected in the second half of 2020, with interim results expected in early 2020.