Additional trials are planned for the antibody, including for chronic obstructive pulmonary disease in 2026. Credit: JOURNEY STUDIO7/Shutterstock.com.

Windward Bio has launched the randomised Phase II POLARIS trial of the long-acting dosing of the recombinant, fully human monoclonal antibody, WIN378, in individuals with asthma.

The double-blind, global, placebo-controlled trial aims to assess the safety, efficacy, and dosing of the antibody. Initial data from the study are anticipated by mid-2026.

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Additional trials are planned for the antibody, including for chronic obstructive pulmonary disease (COPD) in 2026.

Windward Bio CEO, board chair, and founder Luca Santarelli said: “WIN378 has the potential to give people with asthma more durable efficacy and greater control over their disease, which can translate into better overall outcomes.

“POLARIS is our first step towards transforming the care for people living with serious immune-related conditions, including asthma and COPD.”

This January, it was reported that Kelun-Biotech and Harbour BioMed had formed a partnership with Windward Bio, granting it exclusive license for the research, development, production and commercialisation of WIN378 on a global scale, excluding Greater China and certain countries in Southeast and West Asia.

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WIN378 is designed to have a significantly extended half-life and silenced effector function.

A Phase I trial confirmed that the antibody’s half-life for extended dosing and established that the treatment was safe and well-tolerated up to the highest tested dose.

WIN378 targets the thymic stromal lymphopoietin (TSLP) ligand, a critical cytokine implicated in various immunological diseases.

The therapeutic blockade of TSLP has shown clinically meaningful efficacy in treating asthma, COPD, and chronic rhinosinusitis with nasal polyps (CRSwNP).

Ongoing trials in additional diseases highlight the potential of WIN378 as a foundational treatment across various inflammatory phenotypes.

The National Medical Products Administration (NMPA) approved an investigational new drug (IND) application for WIN378 to treat COPD in January.

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