Aslan announces interim results from Phase 2 study of eblasakimab

ASLAN Pharmaceuticals announced interim results from the Phase 2 study of eblasakimab in moderate-to-severe atopic dermatitis adult patients previously treated with dupilumab, TREK-DX. The primary endpoint, which is the percent change in Eczema Area Severity Index score from baseline to week 16, was statistically significant when compared to placebo, even though the interim analysis was not powered for statistical significance due to the sample size. 73.3% of eblasakimab-treated patients achieved a reduction in EASI score of at least 75% from baseline compared to 14.3% on placebo. Summary of the interim data: The TREK-DX trial is enrolling moderate-to-severe adult AD patients who have discontinued dupilumab treatment for any reason, including inadequate control of AD, loss of access or an adverse event, after at least 16 weeks of dupilumab treatment. In an interim analysis of data from 22 patients, comprising the intent-to-treat population, that were randomized 2:1 active to placebo, 17 patients completed the 16-week treatment period and five patients discontinued before the completion of the 16-week treatment period. Patients treated with eblasakimab 400mg once weekly saw a rapid onset of action in the first few weeks of treatment, with a statistically significant improvement in EASI score by Week 4 compared to placebo. By Week 16, a 86.9% mean reduction4 in EASI score from baseline was observed for eblasakimab-treated patients compared to a 51.2% reduction for placebo. Clinically meaningful improvements were achieved in other key efficacy measures compared to placebo at Week 16, including: 73.3% of eblasakimab-treated patients achieved EASI-75, versus 14.3% on placebo. 60.0% of eblasakimab-treated patients achieved EASI-90, versus 14.3% on placebo. 20.0% of eblasakimab-treated patients achieved EASI-100, versus 0% on placebo. 66.7% of eblasakimab-treated patients achieved a vIGA score of 0 or 1, versus 14.3% with placebo. 58.9% mean reduction in peak pruritus numerical rating scale score for eblasakimab-treated patients, versus a 12.9% reduction for placebo. 53.8% of eblasakimab-treated patients, with a baseline score of at least 4, achieved a 4-point reduction in PP-NRS score, versus 14.3% on placebo. Of the six patients treated with eblasakimab who previously had an inadequate response to dupilumab, 66.7% achieved EASI-90 and 66.7% achieved a vIGA score of 0 or 1. Treatment was well-tolerated and no new safety signals were identified. There were no reports of conjunctivitis or injection site reactions in the active or placebo arm. Summary of data from subgroup with baseline EASI score of 18 or above: As previously announced, the TREK-DX recruitment criteria were tightened in October 2023 to enroll only patients with a baseline EASI score of 18 or above. These more stringent criteria will be the basis of analysis in the topline readout, expected at the end of 2024. Of the 22 patients in this interim analysis, 15 meet these amended enrollment criteria, and have the following efficacy findings at Week 16: 89.2% mean reduction in EASI score from baseline for eblasakimab-treated patients, versus a 45.7% reduction for placebo. 83.3% of eblasakimab-treated patients achieved EASI-75, versus 0% on placebo. 66.7% of eblasakimab-treated patients achieved EASI-90, versus 0% on placebo. 25% of eblasakimab-treated patients achieved EASI-100, versus 0% on placebo. 75.0% of eblasakimab-treated patients achieved a vIGA score of 0 or 1, versus 0% with placebo. 61.2% mean reduction in PP-NRS score for eblasakimab-treated patients, versus a 1.5% increase for placebo. 60% of eblasakimab-treated patients, with a baseline score of least 4, achieved a 4-point reduction in PP-NRS score, versus 0% on placebo. The interim data will be submitted for presentation at an upcoming scientific conference.