Aslan Pharmaceuticals presents data from Phase 2b study of eblasakimab

ASLAN Pharmaceuticals announced the late-breaking oral presentation of data from the Phase 2b TREK-AD study of eblasakimab in adults with moderate-to-severe atopic dermatitis at the 32nd European Academy of Dermatology and Venereology Congress. Eric L. Simpson, MD, Frances J. Storrs Professor of Medical Dermatology at the Oregon Health and Science University and Lead Investigator in the TREK-AD study, presented the topline findings from the study, which were previously announced in July. Eblasakimab met the primary endpoint of percent change from baseline in the Eczema Area and Severity Index score at week 16 versus placebo with statistical significance in three dosing arms: 600mg dosed once every four weeks, which was numerically the best performing arm, 400mg dosed once every two weeks and 300mg dosed once every two weeks. Patients treated with eblasakimab at these doses saw a rapid onset of action in the first few weeks of treatment, with a statistically significant improvement in EASI score by week four. Eblasakimab was generally well-tolerated at all dose levels, with low rates of conjunctivitis and injection site reactions. New data was also presented at the EADV Congress based on a post-hoc analysis of patients with severe AD. This subgroup had a median baseline EASI score of 31.1 compared to 24.0 in the ITT population. Results from the subgroup analysis demonstrate comparable efficacy in response to eblasakimab treatment to that in the ITT population, but a marked reduction in placebo response. In the 600mg Q4W arm, the placebo-adjusted reduction in EASI score widened to 36.5% from 21.9% the placebo-adjusted EASI-75 widened to 40.7% from 27.6%, and the placebo-adjusted vIGA-AD widened to 23.0% from 16.1% . Positive data from TREK-AD, a Phase 2b study of eblasakimab in adults with moderate-to-severe AD, showed eblasakimab has the potential to deliver a monthly dosing regimen from initiation without compromising on efficacy. 289 patients were randomized in the ITT population to eblasakimab once-monthly at 400mg or 600mg, or once every two weeks at 300mg or 400mg, or placebo Q2W for 16 weeks, following two or three loading doses. A subpopulation post-hoc analysis of those with a baseline EASI score of at least 21 were performed. In the ITT population, improvement of EASI scores was significantly greater at week 16 for eblasakimab doses 600mg Q4W, 400mg Q2W and 300mg Q2W vs placebo, respectively. In the analysis of the subgroup of patients who had an EASI score of at least 21 at baseline, differences in EASI percent change from baseline at week 16 between eblasakimab-treated groups versus placebo were greater compared to the ITT population: -74.5% in 600mg Q4W, -72.7% in 400mg Q2W, -69.8% in 300mg Q2W, and -60.2% in eblasakimab 400mg Q4W versus -38.0% in the placebo arm. In the subgroup analysis, the percentage of patients achieving EASI-75 were:, 53.6% in 600mg Q4W, 49.7% in 400mg Q2W, 52.1% in 300mg Q2W, and 36.1% in 400mg Q4W versus 12.9% in the placebo arm. The percentage of patients achieving a validated Investigator Global Assessment of Atopic Dermatitis score of 0/1 were as follows:, 29.8% in 600mg Q4W, 37.6% in 400mg Q2W, 27.1% in 300mg Q2W, and 9.6% in 400mg Q4W versus 6.8% in the placebo arm. Overall, discontinuation rates were comparable between the active treatment arms and higher in the placebo arm. Eblasakimab was well tolerated; conjunctivitis and injection site reactions were slightly higher for eblasakimab versus placebo, which was 1.8% for each.