공시 • Mar 29
ASLAN Pharmaceuticals Announces Late-Breaker Presentation of Data From Eblasakimab Proof-of-Concept Study at the 2022 American Academy of Dermatology Annual Meeting
ASLAN Pharmaceuticals announced the oral presentation of data from the completed Phase 1b multiple-ascending-dose study that established proof of concept for eblasakimab (ASLAN004) in moderate-to-severe atopic dermatitis during the late-breaking research session at the 2022 American Academy of Dermatology Annual Meeting on March 26, 2022, in Boston, Massachusetts. The data were presented by Dr Andrew Blauvelt, President, Oregon Medical Research Center. Eblasakimab is a novel, potential first-in-class monoclonal antibody that targets the IL-13 receptor a1 subunit, one of the components of the Type 2 receptor. In the MAD study, which randomized approximately 50 patients with moderate-to-severe AD, eblasakimab demonstrated a statistically significant improvement1 in the primary efficacy endpoint, the mean change from baseline at eight weeks in Eczema Area and Severity Index, as well as significant changes in other key efficacy endpoints, including the proportion of patients achieving at least a 75% improvement in their EASI score, mean change in peak pruritis and mean change in Patient-Oriented Eczema Measure. Eblasakimab was well tolerated and there were no emerging safety concerns. ASLAN is continuing to advance the development of eblasakimab in AD and recently initiated a global Phase 2b trial which is expected to generate topline data in the first half of 2023. The randomized, double-blind, placebo-controlled trial evaluated three doses (200mg, 400mg and 600mg) of eblasakimab delivered weekly via subcutaneous injection, with approximately eight patients in each cohort. Based on a review of blinded safety data, the highest dose, 600mg, was selected for the expansion cohort, which recruited 27 additional patients. Patients were dosed weekly for eight weeks to evaluate the safety and efficacy of eblasakimab. The primary endpoint was safety and tolerability. Secondary endpoints included efficacy at eight weeks as measured by improvement in the EASI score, EASI-50, EASI-75, Investigators Global Assessment (IGA), P-NRS and POEM. The analysis set of 49 patients comprised all patients that were randomized and treated, excluding three patients that were prematurely discontinued due to COVID-19 protocols. Eblasakimab demonstrated a dose-dependent improvement in mean percent change in EASI at week 8. Patients receiving 600mg QW eblasakimab showed a mean reduction in EASI of 61% (n=22), patients receiving 400mg 63% (n=7), patients receiving 200mg 50% (n=4) and patients on placebo 32% (n=16). The proportion of patients each achieving EASI-75 were similar at all dose levels: 50% at 600mg (n=22), 57% at 400mg (n=7), 50% at 200mg (n=4) and 13% on placebo (n=16). At 600mg, significant improvements in the mean change from baseline in EASI versus placebo were observed at week 8 (-61% versus -32%, p=0.0232). Other doses were not tested for significance. Additional secondary endpoints also showed significant improvements versus placebo, including the proportion of patients achieving EASI-50 (77% versus 38%, p=0.016), EASI-75 (50% versus 13%, p=0.018) and mean reduction from baseline P-NRS (37% versus 16%, p=0.032). In the 600mg dose cohort, eblasakimab was shown to induce a meaningful reduction in patients’ EASI score from baseline and P-NRS after just one dose. Improvements in EASI and P-NRS continued to be seen at week 8, suggesting that further improvements may be seen when patients are dosed with eblasakimab for longer than 8 weeks, consistent with findings from other 16-week AD studies targeting the same pathway. The proportion of patients with adverse events and treatment-related adverse events were similar across treatment and placebo arms. There were no treatment-related adverse events in the active arm that led to discontinuation.