Half-Life-Extended Bispecific Antibody Advances Into Clinical Testing for Mild-to-Moderate Asthma
Vial, a clinical-stage biotechnology company, announced that it has dosed the first patient in its Phase 1b clinical study of IL-13 x TSLP, an investigational bispecific antibody being developed for asthma and other atopic and inflammatory diseases.
The Phase 1b study follows the completion of five single ascending dose cohorts in healthy adults, evaluating intravenous doses ranging from 15 mg to 800 mg. Across these cohorts, IL-13 x TSLP was generally well tolerated and demonstrated an extended pharmacokinetic profile with potential to support ultra-long-acting dosing.
Key Highlights
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First patient dosed in the Phase 1b study.
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Study population: adults with mild-to-moderate asthma.
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Phase 1a evaluated doses from 15 mg to 800 mg IV.
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IL-13 x TSLP was generally well tolerated across evaluated dose levels.
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Demonstrated an extended pharmacokinetic profile.
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Designed with half-life extension engineering intended to potentially enable twice-yearly dosing.
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Phase 1b will evaluate safety, pharmacokinetics, immunogenicity, lung function, and Type 2 inflammation biomarkers.
Phase 1b Study Design
The Phase 1b study is a randomized, double-blind, placebo-controlled clinical trial in adults with mild-to-moderate asthma.
Primary Endpoint
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Safety and tolerability
Secondary & Exploratory Endpoints
The study will also evaluate:
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Pharmacokinetics (PK)
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Immunogenicity
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Change from baseline in fractional exhaled nitric oxide (FeNO)
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Lung function (FEV1)
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Pharmacodynamic biomarkers of Type 2 inflammation
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TARC (CCL17)
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Blood eosinophils
The study data are expected to help determine appropriate dose and dosing intervals and inform future development in other atopic and inflammatory diseases.
IL-13 x TSLP: A Dual-Target Approach
Vial’s IL-13 x TSLP is a novel IgG1-based bispecific antibody designed to simultaneously target IL-13 and thymic stromal lymphopoietin (TSLP).
The dual-target approach is intended to address both the initiation and effector arms of Type 2 inflammation.
Program Features
According to Vial, preclinical data support a potentially best-in-class profile characterized by:
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Picomolar dual-target binding
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Potent inhibition of Type 2 signaling
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Inhibition of CCL17 secretion
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Favorable developability characteristics
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Potential for an extended dosing interval
The program is initially being developed for asthma, with potential expansion into other atopic and inflammatory diseases.
CEO Perspective
“Moving into patients is the defining step for Vial's IL-13 x TSLP program. Our Phase 1a data in healthy volunteers showed the safety and pharmacokinetic profile the program 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.”
— Simon Burns, CEO of Vial
About Vial
Vial is a clinical-stage biotechnology company based in San Francisco, focused on addressing unmet needs in Immunology & Inflammation through the development of potentially best-in-class biologics.
Founded in 2020, the company brings together expertise across:
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R&D
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Clinical Development
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Clinical Operations
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Engineering
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Product
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Design
Learn more: www.vial.com
