Clinical-stage biotechnology company Vial has dosed the first patient in its Phase Ib clinical study evaluating interleukin-13 × thymic stromal lymphopoietin (IL-13 x TSLP) in patients diagnosed with mild-to-moderate asthma.
The therapy is a half-life-extended, immunoglobulin G1 (IgG1)-based bispecific antibody engineered to target both IL-13 and TSLP to address the initiation and effector pathways of Type 2 inflammation.
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Although initial clinical work is centred on asthma, the development programme holds potential for future expansion into other inflammatory and atopic conditions.
The Phase Ib trial is structured as a placebo-controlled, double-blind, randomised investigation in an adult population. Its primary objective is to evaluate the safety and tolerability.
Beyond safety, investigators will examine secondary and exploratory endpoints, including pharmacokinetics and immunogenicity.
The study will also evaluate lung function measured by forced expiratory volume in one second (FEV1), changes from baseline in fractional exhaled nitric oxide (FeNO), and pharmacodynamic biomarkers of Type 2 inflammation, such as blood eosinophils and thymus and activation-regulated chemokine (TARC/CCL17).
Data generated from the trial will guide dose and dosing-interval selection alongside broader clinical planning.
Vial CEO Simon Burns said: “Moving into patients is the defining step for Vial’s IL-13 x TSLP programme. Our Phase Ia data in healthy volunteers showed the safety and pharmacokinetic profile the programme was designed to meet.
“We now intend to show that dual IL-13 and TSLP blockade, delivered with an ultra-long-acting dosing interval, can meaningfully improve asthma biomarkers, namely FeNO and FEV1, in patients living with asthma. We look forward to sharing these data as the programme progresses.”
Advancement into patient dosing follows the completion of five single ascending dose cohorts involving healthy adult participants receiving intravenous doses ranging from 15mg to 800mg.
Across those cohorts, the bispecific antibody was generally well tolerated at all evaluated dose levels and displayed an extended pharmacokinetic profile designed to support ultra-long-acting, twice-yearly administration.
Preclinical assessments demonstrated picomolar dual-target binding, potent inhibition of Type 2 signalling including CCL17 secretion, and developability characteristics that support the extended dosing schedule.
