Benzinga | Jan 21, 2022 05:19AM EST

ASLAN Pharmaceuticals Initiates Phase 2b Study Of ASLAN004 In Moderate-To-Severe Atopic Dermatitis



* The TRials with EblasaKimab in Atopic Dermatitis (TREK-AD) study will evaluate the efficacy and safety of ASLAN004, now known as eblasakimab, a potential first-in-class antibody targeting the IL-13 receptor

* This dose-ranging study is expected to enroll approximately 300 patients and will evaluate 4 dose regimens

* Topline results are expected in 1H 2023

MENLO PARK, Calif. and SINGAPORE, Jan. 20, 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 Phase 2b dose-ranging clinical study of eblasakimab in adults with moderate-to-severe atopic dermatitis (AD). Eblasakimab is a potential first-in-class monoclonal antibody targeting the IL-13 receptor that has the potential to provide a differentiated treatment option for patients. ASLAN expects to report topline findings from the 16-week treatment period in the first half of 2023.

The randomized, double-blind, placebo-controlled, dose-ranging clinical study will evaluate the efficacy and safety of eblasakimab in adult patients with moderate-to-severe AD who are candidates for systemic therapy. The TREK-AD study will randomize patients equally to four active treatment arms and one placebo arm, evaluating eblasakimab 300mg dosed every two weeks, 400mg dosed every two weeks, 400mg dosed every four weeks and 600mg dosed every four weeks.

The study is expected to enroll approximately 300 adult patients across 100 sites in North America, Europe and Asia Pacific and will consist of a 16-week treatment period and a 12-week safety follow-up period. The primary efficacy endpoint is percentage change in Eczema Area Severity Index (EASI) score from baseline to week 16. Key secondary efficacy endpoints 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), proportion of patients achieving EASI-50 and EASI-90, and changes in peak pruritus. Further details are available via ClinicalTrials.gov (study ID NCT05158023).

Dr Carl Firth, CEO, ASLAN Pharmaceuticals, commented, "We are pleased to have initiated this important new study evaluating eblasakimab in moderate-to-severe AD patients. Building upon the positive data we recently announced from the Proof-of-Concept study, the Phase 2b program will enable us to evaluate its potential as a novel treatment option that could provide meaningful improvements over existing therapies. This is a key milestone for ASLAN and moves us closer towards demonstrating the positive impact that eblasakimab could have on the burden of disease for atopic dermatitis and for other Type 2 driven allergic diseases."