Vial, a clinical-stage biotechnology company, has dosed the first patient in its phase 1b clinical study of Vial’s IL-13 x TSLP in patients with mild-to-moderate asthma.
IL-13 x TSLP is a novel, half-life-extended bispecific antibody in development for the treatment of asthma and other atopic and inflammatory diseases.
The phase 1b study follows completion of five single ascending dose cohorts in healthy adult volunteers at doses from 15 mg to 800 mg IV. In those cohorts, IL-13 x TSLP was generally well tolerated at all dose levels and showed an extended pharmacokinetic profile with the potential to support ultra-long-acting dosing.
The IL-13 x TSLP phase 1b study is a randomised, double-blind, placebo-controlled study in adults with mild-to-moderate asthma. The primary endpoint is safety and tolerability. Secondary and exploratory endpoints include pharmacokinetics, immunogenicity, change from baseline in FeNO, lung function (FEV1), and pharmacodynamic biomarkers of type 2 inflammation, including TARC (CCL17) and blood eosinophils. Data from this study are expected to inform dose and dosing-interval selection, as well as future development in other atopic and inflammatory diseases.
