Windward Bio Initiates Global Phase 2 Asthma Trial of WIN378, a Potential Best-in-Disease, Long-Acting, Anti-TSLP Monoclonal Antibody

• Phase 2 POLARIS trial will evaluate the dosing, safety, and efficacy of WIN378 in patients with asthma, with a first data readout expected in mid-2026
• WIN378 has the potential to be the first-to-market long-acting, anti-TSLP antibody with twice-yearly dosing in asthma and COPD
• Improved dosing convenience can meaningfully reduce treatment burden and improve outcomes for people living with advanced respiratory diseases
• COPD clinical program planned to start in mid-2026

BASEL, Switzerland, July 23, 2025 (GLOBE NEWSWIRE) -- Windward Bio AG, a private, clinical-stage biotechnology company committed to improving outcomes for people living with advanced immunological diseases, today announced the launch of its Phase 2 POLARIS clinical study, assessing the long-acting dosing of WIN378 for people living with asthma.

WIN378 is a novel, recombinant, fully human monoclonal antibody engineered to have a significantly extended half-life and silenced effector function. WIN378 has been studied in a Phase 1 trial which confirmed the half-life for extended dosing, demonstrated a low rate of antidrug antibodies, and was safe and well tolerated up to the highest tested dose. WIN378 potently binds to the thymic stromal lymphopoietin (TSLP) ligand, a key cytokine in the development and progression of a wide array of immunological diseases.

Therapeutic blockade of the TSLP ligand is a well-validated approach that has demonstrated clinically meaningful efficacy in asthma, chronic obstructive pulmonary disease (COPD), and chronic rhinosinusitis with nasal polyps (CRSwNP). Studies are underway in additional diseases, underscoring its potential as a foundational pathway across diverse inflammatory phenotypes.

“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,” said Luca Santarelli, MD, Founder, Chief Executive Officer, and Board Chair. “POLARIS is our first step towards transforming the care for people living with serious immune-related conditions, including asthma and COPD."

The Phase 2 POLARIS trial is a global, randomized, double-blind, placebo-controlled study evaluating the dosing, safety, and efficacy of WIN378 in patients with asthma. Initial data are expected in mid-2026.

Additional clinical trials are planned with WIN378, including in COPD in 2026. More than 5 million people are living with advanced, uncontrolled asthma and COPD in the United States, Europe, and Japan who could benefit from the potential of improved adherence and outcomes of long-acting treatments.

Windward Bio is also building a discovery pipeline of long-acting bi-specific antibodies harnessing validated targets and synergistic biology to achieve best-in-disease efficacy for immunology indications.

About WIN378

WIN378 is a next-generation, recombinant, fully human monoclonal antibody that potently binds to the TSLP ligand, a well-validated cytokine that plays a key role in the development and progression of a wide array of immunological diseases, including asthma and COPD. WIN378 has been engineered to achieve a half-life extension (HLE) and a silenced effector function and is subcutaneously administered. WIN378 has been studied in a Phase 1 trial which confirmed the half-life for extended dosing, demonstrated a low rate of antidrug antibodies, and was safe and well tolerated up to the highest tested dose. Windward Bio licensed in the global rights (excluding Greater China and several Southeast and West Asian countries) of WIN378 from Kelun-Biotech (previously known as SKB378) and Harbour BioMed (previously known as HBM9378).

WIN378 is currently being evaluated in the Phase 2 POLARIS trial for adults living with asthma.

About Windward Bio AG

Windward Bio is a clinical-stage biotechnology company with deep discovery, development, and commercialization expertise committed to transforming the treatment of people living with advanced immunological conditions. Its lead program is WIN378, a potential best-in-disease, long-acting, anti-TSLP monoclonal antibody in Phase 2 for asthma. The company is planning additional clinical studies of WIN378 in COPD and other respiratory indications and is also building a pipeline of long-acting bi-specific antibodies targeting validated biology in respiratory and dermatological conditions. Windward Bio launched earlier this year with a $200M Series A led by top-tier investors.

Contacts

For media, business, or investor inquiries, please contact: media@windwardbio.com

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