Windward Bio is evaluating WIN378, a monoclonal antibody designed for twice-yearly dosing in patients with moderate-to-severe COPD.
RT’s Three Key Takeaways:
- Phase 2 Initiation: Windward Bio has dosed the first patients in its SIRIUS study to evaluate the safety and efficacy of WIN378 for patients with moderate-to-severe chronic obstructive pulmonary disease.
- Extended Dosing Potential: The treatment is designed for twice-yearly subcutaneous administration, which could provide disease control with less frequent dosing than current biologic options.
- Clinical Program Expansion: The start of the COPD trial expands the development of WIN378 beyond the company’s ongoing asthma studies, with initial Phase 2 asthma data expected in late 2026.
Windward Bio announced that the first patients have been dosed in the Phase 2 SIRIUS study of WIN378, an ultra long-acting monoclonal antibody, for the treatment of COPD, according to the company.
COPD is a progressive lung disease and the third-leading cause of death globally, driven by immune-mediated airway inflammation and persistent airflow obstruction. Despite existing inhaled background therapies, more than 3 million patients with moderate-to-severe COPD remain at high risk of recurrent exacerbations, which are sudden flare-ups that lead to emergency room visits, hospitalizations, and lasting declines in lung function, Windward Bio stated in the release.
“People living with COPD face significant morbidity and mortality from exacerbations, which take a devastating toll on lung function and quality of life. Today’s biologic options are limited, and all require frequent dosing,” said Omar Khwaja MD, PhD, chief medical officer, in a news release. “We believe WIN378 has the potential to deliver longer-lasting disease control with substantially less frequent dosing, an advance that could meaningfully address the unmet needs of people living with COPD.”
SIRIUS is a global, randomized, double-blind, placebo-controlled, dose-finding study. The trial is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of WIN378 in patients with moderate-to-severe COPD.
WIN378 is a fully human monoclonal antibody that inhibits the thymic stromal lymphopoietin (TSLP) ligand, a target that plays a key role in the development of immunological diseases, including asthma and COPD. The drug has been engineered for half-life extension and silenced effector function. In a Phase 1 trial, the treatment demonstrated an extended half-life suitable for twice-yearly subcutaneous dosing and was safe and well tolerated, the company reported.
The initiation of the SIRIUS trial marks an expansion of Windward Bio’s respiratory development program, which also includes the ongoing Phase 2/3 POLARIS study in asthma. The Phase 2 portion of the asthma study is fully enrolled, with initial data expected in the second half of 2026. The company expects to initiate the first Phase 3 study of WIN378 in asthma by the fourth quarter of 2026, according to the release.
