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18th July 2023
Eblasakimab is the first biologic treatment for moderate to severe atopic dermatitis to show a competitive efficacy profile when given as a once-monthly dose, according to data released by the manufacturer, Aslan pharmaceuticals.
The novel monoclonal antibody targets the interleukin-13 (IL-13) receptor subunit of the Type 2 receptor, that is a key pathway in several allergic inflammatory diseases, including atopic dermatitis.
The findings, while yet to be published, relate to the phase 2b TREK-AD study, which randomised patients to one of five eblasakimab dosing arms for a total of 16 weeks: 300 mg every two weeks, 400 mg every two weeks, 400 mg every four weeks, 600 mg every four weeks or a placebo.
The study’s primary endpoint was the percentage change from baseline in the Eczema Area and Severity Index (EASI) score at week 16 versus placebo. The study also included a validated Investigator Global Assessment of Atopic Dermatitis (vIGA-AD) score of 0/1 (i.e. clear or almost clear).
A total of 289 patients were randomised and treated in the intent-to-treat (ITT) population across the five dosing arms. Patients treated with eblasakimab 600mg, 400mg and 300mg, all saw a rapid onset of action in the first few weeks of treatment, with a statistically significant improvement in EASI score by Week 4.
When assessed at Week 16, some 62.7% of eblasakimab patients given 600 mg monthly achieved a reduction of at least 75% from baseline (EASI-75) compared to 30.7% given the placebo (p = 0.0041).
In addition, 34.1% of eblasakimab patients receiving the 600 mg dose, achieved an EASI90, compared to only 10.1% on the placebo (p = 0.0088).
Finally, 31.2% of these patients achieved vIGA-AD score of 0 or 1 compared to 15.1% with the placebo (p = 0.0502).
No new safety signals were seen in the study, and the frequency of adverse events was comparable between the active eblasakimab treatment and placebo arms, with the most frequently observed adverse events being nasopharyngitis (13.4% vs 8.8% for placebo), atopic dermatitis (8.6% vs 7.0% for placebo), headache (6.9% vs 7.0% for placebo) and upper respiratory tract infection (6.5% vs 5.3% for placebo).
Commenting on these findings, Eric L. Simpson, lead investigator in the TREK-AD study and Frances J. Storrs Professor of Medical Dermatology at the Oregon Health and Science University, said: ‘This is the first time we’ve seen a once-a-month treatment option deliver competitive efficacy data, which would be a game-changer for patients with atopic dermatitis.
‘We haven’t seen much in the way of advancement since the launch of dupilumab, and there remains a huge unmet burden of disease experienced by patients. These results support eblasakimab’s potential to be a leading therapy for the treatment of atopic dermatitis, if approved.‘