- The TRials with EblasaKimab in Atopic Dermatitis (TREK-AD) study has enrolled the final patient
- Topline results expected in early July 2023
San Mateo, California, and Singapore, February 24, 2023 – ASLAN Pharmaceuticals (“ASLAN”, Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced that it has enrolled the final patient in TREK-AD, a Phase 2b dose-ranging clinical study of eblasakimab in adults with moderate-to-severe atopic dermatitis (AD). ASLAN expects to report topline data from this study in early July 2023.
The randomized, double-blind, placebo-controlled, dose-ranging clinical study, TREK-AD, was initiated in early 2022 to evaluate the efficacy and safety of eblasakimab in biologic naïve AD patients during a 16-week treatment period and a 12-week safety follow-up period. The study has enrolled patients from more than 80 sites across North America, Europe and Asia Pacific. The primary efficacy endpoint is the percentage change in Eczema Area Severity Index (EASI) score from baseline to week 16. Secondary efficacy endpoints include the proportion of patients achieving validated Investigator Global Assessment (vIGA) score of 0 (clear) or 1 (almost clear), proportion of patients with a 75% or greater reduction in EASI (EASI-75), proportion of patients achieving EASI-50 (50% or greater reduction) and EASI-90 (90% or greater reduction), and changes in peak pruritus scores.
“We are pleased to have enrolled the final patient in the TREK-AD study and look forward to sharing topline results from this important study in early July 2023. The findings will provide greater clarity on eblasakimab’s differentiation and, combined with data from the ongoing TREK-DX study, will support its potential as a biologic of first-choice for AD patients,” said Dr Alex Kaoukhov, CMO, ASLAN Pharmaceuticals. “We are grateful to all patients, physicians, and trial investigators involved in the study. Their involvement is testament to the need that exists for new therapies to treat AD.”
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 early July 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 the first quarter of 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 the global Phase 2b TREK-AD trial of moderate-to-severe AD patients and the Phase 2 TREK-DX trial in dupilumab-experienced AD patients. ASLAN is also developing farudodstat, a potent next-generation oral inhibitor of the enzyme DHODH, and plans to initiate a Phase 2 trial in an autoimmune skin 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. 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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