Singapore-based biopharmaceutical company ASLAN Pharmaceuticals has announced positive interim data from its Phase II TREK-DX study of eblasakimab, a drug candidate for moderate-to-severe atopic dermatitis (AD) in adults.
The randomised, double-blind, placebo-controlled trial enrolled 75 subjects across North America and Europe.
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It is designed to assess eblasakimab’s efficacy and safety in people who had previously received the dupilumab treatment but did not finish it for various reasons.
The study includes a 16-week treatment period followed by an eight-week safety follow-up.
The percentage change in the Eczema Area Severity Index (EASI) score from baseline to week 16 is the trial’s primary efficacy endpoint.
Key secondary endpoints include the proportion of subjects attaining Investigator Global Assessment (vIGA) score of zero (clear) or one (almost clear), as well as a 75% or greater reduction in EASI (EASI-75) score.
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By GlobalDataAn interim analysis data from 22 patients showed a statistically significant change in the primary endpoint compared to placebo.
In addition, 73.3% of subjects treated with eblasakimab achieved an EASI-75 response, as opposed to 14.3% of patients given placebo.
By the end of week 16, subjects in the eblasakimab arm experienced an 86.9% mean reduction in their EASI score from baseline, significantly higher than the 51.2% reduction observed in the placebo group.
Eblasakimab treatment was well-tolerated in the trial, without any new safety concerns reported.
ASLAN Pharmaceuticals CEO Dr Carl Firth said: “Most patients on eblasakimab achieved EASI-90 and vIGA of 0 or 1 after just 16 weeks of treatment, with numbers unprecedented in other biologics AD studies.
“Notably, in patients that previously had an inadequate response to dupilumab, two-thirds achieved EASI-90 and vIGA 0 or 1 when treated with eblasakimab.”
Last May, ASLAN Pharmaceuticals announced it had enrolled the final subject in the TREK-AD trial of eblasakimab to treat moderate-to-severe AD.
