- The TRials with EblasaKimab in Dupilumab eXperienced atopic dermatitis patients (TREK-DX) study will evaluate eblasakimab in a patient population with few safe treatment options
- The study will enroll 75 patients in North America with topline results expected in the first quarter of 2024
- Study is fully funded with no impact on previously reported cash runway
- Data from TREK-DX and TREK-AD could support the use of eblasakimab for both biologic naïve and experienced AD patients
SAN MATEO, Calif. and SINGAPORE, Dec. 15, 2022 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced that it has screened the first patient in its TREK-DX study of eblasakimab in adult patients with moderate-to-severe atopic dermatitis (AD) who have previously been treated with dupilumab. Eblasakimab is a potential first-in-class monoclonal antibody targeting the IL-13 receptor that has the potential to deliver a differentiated efficacy and safety profile.
The randomized, double-blind, placebo-controlled, Phase 2 clinical trial is expected to enroll 75 patients in North America and will assess the efficacy and safety of eblasakimab in dupilumab experienced patients who have discontinued their treatment for any reason, including inadequate disease control, loss of access to drug or an adverse event. TREK-DX will enable ASLAN to test a once-weekly dosing regimen of 400mg of eblasakimab, which has previously been shown to be safe and well-tolerated in Phase 1 studies that may be the most effective option to address the severity and refractory nature of the disease that these patients experience. It is thought that eblasakimab, with a unique mechanism of action blocking the IL-13 receptor directly and therefore providing complete but specific blockade of the Type 2 receptor, could show benefit in patients who have discontinued treatment with dupilumab.
TREK-DX will provide support to TREK-AD, a trial that is investigating eblasakimab in biologic naïve patients, and could help to strengthen the positioning of eblasakimab as the biologic of first choice for AD treatment. Topline data from TREK-DX is expected in the first quarter of 2024.
“We are extremely pleased to have screened our first patient in TREK-DX, an important new study that will generate valuable data on eblasakimab in the dupilumab experienced AD population. For patients who have failed or do not achieve a satisfactory response on dupilumab, there are few safe treatment options – and patients should not need to compromise on safety,” said Carl Firth, CEO, ASLAN Pharmaceuticals.
About the TREK-DX trial design
Participants will be randomized in a 2:1 ratio of treatment with eblasakimab or placebo and dosed with a subcutaneous injection of 400mg of eblasakimab weekly for 16 weeks, followed by an 8-week safety follow-up period. The primary efficacy endpoint in the study is percentage change in Eczema Area Severity Index (EASI) score from baseline to week 16. Key secondary efficacy endpoints at week 16 include the proportion of patients achieving Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear), proportion of patients with a 75% or greater reduction in EASI (EASI-75), percentage of patients achieving EASI-50 and EASI-90, and changes in peak pruritus.
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 atopic dermatitis (AD). Positive results from a Phase 1b multiple-ascending-dose study established proof-of-concept for eblasakimab and supported its potential as a novel, differentiated treatment for AD. ASLAN is currently conducting TREK-AD, a Phase 2b trial to evaluate eblasakimab in biologic naïve moderate-to-severe AD patients, with topline readout expected in 2Q 2023. ASLAN is also investigating eblasakimab in dupilumab experienced, moderate-to-severe AD patients in the Phase 2 trial TREK-DX, with data expected in 1Q 2024.
About ASLAN Pharmaceuticals
ASLAN Pharmaceuticals (Nasdaq: ASLN) is a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients. ASLAN is developing eblasakimab, a potential first-in-class antibody targeting the IL-13 receptor in moderate-to-severe atopic dermatitis (AD) with the potential to improve upon current biologics used to treat allergic disease. Eblasakimab is being investigated in a global Phase 2b trial of moderate-to-severe AD patients with topline readout expected in 2Q 2023. ASLAN is also developing farudodstat, a potent next-generation oral inhibitor of DHODH, and plans to initiate a Phase 2 trial in skin autoimmune disease in the first half of 2023. ASLAN has teams in San Mateo, California, and in Singapore. For additional information please visit www.aslanpharma.com or follow ASLAN on LinkedIn.
This release contains forward-looking statements. These statements are based on the current beliefs and expectations of the management of ASLAN Pharmaceuticals Limited and/or its affiliates (the "Company"). These forward-looking statements may include, but are not limited to, statements regarding the Company’s business strategy and clinical development plans; the Company’s plans to develop and commercialize eblasakimab and farudodstat; the safety and efficacy of eblasakimab and farudodstat; the Company’s plans and expected timing with respect to clinical trials, clinical trial enrollment and clinical trial results for eblasakimab and farudodstat; and the potential of eblasakimab as a first-in-class treatment for atopic dermatitis and of farudodstat as a treatment for autoimmune disease; and the Company’s cash runway. 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; clinical site activation rates or clinical trial enrollment rates that are lower than expected; the impact of the COVID-19 pandemic or the ongoing conflict between Ukraine and Russia on the Company’s business and the global economy; 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 US Securities and Exchange Commission filings and reports (Commission File No. 001- 38475), including the Company’s Annual Report on Form 20-F filed with the US Securities and Exchange Commission on March 25, 2022. All statements other than statements of historical fact are forward-looking statements. The words “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify estimates, projections, and other forward-looking statements. Estimates, projections, and other forward-looking statements speak only as of the date they were made, and, except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement.
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