Windward Bio has launched its Phase 2 POLARIS clinical trial to assess the long-acting dosing of WIN378, an anti-TSLP antibody, for asthma patients. The trial will evaluate the drug’s dosing, safety, and efficacy, with preliminary results expected in mid-2026. WIN378 aims to be the first twice-yearly anti-TSLP antibody for asthma and COPD, potentially improving patient outcomes by reducing treatment burden.
The potential for a twice-yearly dosing regimen for WIN378 addresses a significant unmet need in respiratory disease management. Current treatment options often require frequent administration, which can lead to poor adherence and suboptimal disease control. A less frequent dosing schedule could significantly improve patient compliance, leading to better outcomes and a higher quality of life for individuals with asthma and COPD. This innovation has the potential to reshape the treatment landscape for chronic respiratory diseases.
WIN378 is a fully human monoclonal antibody engineered for extended half-life and silenced effector function. Phase 1 trials have confirmed the extended half-life, demonstrated a low rate of antidrug antibodies, and shown the drug to be safe and well-tolerated. The Phase 2 POLARIS trial is a global, randomized, double-blind, placebo-controlled study. Windward Bio also plans to initiate clinical trials for WIN378 in COPD patients in 2026.
The success of the POLARIS trial could pave the way for a new era in asthma and COPD management. Positive results could validate the long-acting approach, potentially leading to faster regulatory approval and market entry. This could offer patients a more convenient and effective treatment option, ultimately improving their respiratory health and overall well-being. Further, the development of WIN378 strengthens Windward Bio’s position in the immunology field and could lead to advancements in other respiratory and dermatological conditions using similar long-acting biologic approaches.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
