- Interim readout of 22 patients shows unprecedented efficacy data compared to prior atopic dermatitis (AD) studies with biologics: 60.0% of dupilumab-experienced AD patients treated with 400mg eblasakimab weekly achieved
EASI -90 (at least a 90% reduction in their Eczema Area Severity Index (EASI) score) and 66.7% achieved a vIGA score of 0 or 1 (clear or almost clear skin) after 16 weeks, versus 14.3% of patients on placebo. - 20% of patients treated with eblasakimab achieved
EASI -100 (100% reduction in theirEASI score) versus 0% on placebo. - Of the six patients treated with eblasakimab that previously had an inadequate response to dupilumab, 66.7% achieved
EASI -90 and a vIGA score of 0 or 1 after 16 weeks. - Eblasakimab produced rapid and clinically meaningful itch relief versus placebo. The mean reduction in peak pruritus numerical rating scale (PP-NRS) score for eblasakimab-treated patients was 58.9% compared to a 12.9% reduction for placebo.
- Data from this unique study of dupilumab-experienced AD patients shows eblasakimab has the potential to be highly effective in AD patients even if dupilumab has not been.
“We are extremely pleased to see eblasakimab delivering these spectacular results using a dosing regimen higher than we have tested previously. Most patients on eblasakimab achieved
“We know that over 60% of dupilumab-treated patients fail to achieve an IGA score of 0 or 1 after 16 weeks1, and, of those patients that do achieve it, still half do not maintain it after the subsequent 36 weeks2. The data we have announced today provide compelling evidence that eblasakimab, with its unique mechanism of action, has the potential to be an important new therapy for this emerging patient population. We look forward to announcing the topline readout from the full dataset of the TREK-DX study at the end of this year, the first and only placebo-controlled study of dupilumab-experienced AD patients, and to optimizing the dose regimen for patients in the planned Phase 3 studies of eblasakimab.”
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 (ITT) population, that were randomized 2:1 active to placebo, 17 patients completed the 16-week treatment period and five patients (two in the active arm and three in the placebo arm) discontinued before the completion of the 16-week treatment period3.
Patients treated with eblasakimab 400mg once weekly (n=15) saw a rapid onset of action in the first few weeks of treatment, with a statistically significant improvement in
- 73.3% (11/15) of eblasakimab-treated patients achieved
EASI -75, versus 14.3% (1/7) on placebo (p=0.0431). - 60.0% (9/15) of eblasakimab-treated patients achieved
EASI -90, versus 14.3% (1/7) on placebo (p=0.1278). - 20.0% (3/15) of eblasakimab-treated patients achieved
EASI -100, versus 0% (0/7) on placebo (EASI -100 was not a pre-specified endpoint). - 66.7% (10/15) of eblasakimab-treated patients achieved a vIGA score of 0 or 1, versus 14.3% (1/7) with placebo (p=0.0750).
- 58.9% mean reduction in peak pruritus numerical rating scale (PP-NRS) score for eblasakimab-treated patients, versus a 12.9% reduction for placebo (p=0.0015). 53.8% (7/13) of eblasakimab-treated patients, with a baseline score of at least 4, achieved a 4-point reduction in PP-NRS score, versus 14.3% (1/7) on placebo (p=0.2460).
Of the six patients treated with eblasakimab who previously had an inadequate response to dupilumab, 66.7% (4/6) achieved
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
As previously announced, the TREK-DX recruitment criteria were tightened in
- 89.2% mean reduction in
EASI score from baseline for eblasakimab-treated patients, versus a 45.7% reduction for placebo (p=0.0045). - 83.3% (10/12) of eblasakimab-treated patients achieved
EASI -75, versus 0% (0/3) on placebo (p=0.0556). - 66.7% (8/12) of eblasakimab-treated patients achieved
EASI -90, versus 0% (0/3) on placebo (p=0.1667). - 25% (3/12) of eblasakimab-treated patients achieved
EASI -100, versus 0% (0/3) on placebo (EASI -100 was not a pre-specified endpoint). - 75.0% (9/12) of eblasakimab-treated patients achieved a vIGA score of 0 or 1, versus 0% (0/3) with placebo (p=0.1111).
- 61.2% mean reduction in PP-NRS score for eblasakimab-treated patients, versus a 1.5% increase for placebo (p=0.0004). 60% (6/10) of eblasakimab-treated patients, with a baseline score of least 4, achieved a 4-point reduction in PP-NRS score, versus 0% (0/3) on placebo (p=0.2000).
The interim data will be submitted for presentation at an upcoming scientific conference.
About the TREK-DX study
TREK-DX (TRials in EblasaKimab in Dupilumab eXperienced AD patients) is the first randomized, double-blind, placebo-controlled trial to be conducted in AD patients who have been previously treated with dupilumab. The trial is expected to enroll 75 patients across sites in
References
- Thaci et al (2019) J Dermatol Sci 94(2):266-275
- Worm et al (2020) JAMA Derm 156(2):131-143
- One patient in each treatment arm took a rescue medication during the treatment period. Their efficacy data was set to missing (continuous endpoints) or failure (binary endpoints) after initiation of the rescue medication for the purpose of efficacy analyses. Missing data were analysed using Last Observation Carried Forward imputation.
- Least squares (LS) mean
About eblasakimab
Eblasakimab is a potential first-in-class monoclonal antibody targeting the IL-13 receptor subunit of the Type 2 receptor, a key pathway driving several allergic inflammatory diseases. Eblasakimab’s unique mechanism of action enables specific blockade of the Type 2 receptor and has the potential to improve upon current biologics used to treat allergic disease. By blocking the Type 2 receptor, eblasakimab prevents signaling through both interleukin 4 (IL-4) and interleukin 13 (IL-13) – the key drivers of inflammation in AD and Type 2-driven COPD. ASLAN announced positive results from the Phase 2b TREK-AD study of eblasakimab in moderate-to-severe biologic-naïve AD patients in
About
Forward looking statements
This release contains forward-looking statements. These statements are based on the current beliefs and expectations of the management of the Company. These forward-looking statements may include, but are not limited to statements regarding the Company’s business strategy and clinical development plans; statements related to the safety and efficacy of eblasakimab, including interim results; the Company’s plans and expected timing with respect to clinical trials, clinical trial enrollment and clinical trial results for eblasakimab; the potential of eblasakimab as a first-in-class treatment for atopic dermatitis; and expectations regarding the terms of patents and ability to obtain and maintain intellectual property protection for product candidates. The Company’s estimates, projections and other forward-looking statements are based on management's current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations, or financial performance, and inherently involve significant known and unknown risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of many risks and uncertainties, which include, unexpected safety or efficacy data observed during preclinical or clinical studies; risks that future clinical trial results may not be consistent with interim, initial or preliminary results or results from prior preclinical studies or clinical trials; clinical site activation rates or clinical trial enrollment rates that are lower than expected; the impact of health epidemics or pandemics, or geopolitical conflicts on the Company’s operations, research and development and clinical trials and potential disruption in the operations and business of third-party manufacturers, contract research organizations, other service providers and collaborators with whom the Company conducts business; general market conditions; changes in the competitive landscape; and the Company’s ability to obtain sufficient financing to fund its strategic and clinical development plans. Other factors that may cause actual results to differ from those expressed or implied in such forward-looking statements are described in the Company’s
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