Harbour BioMed’s partner Windward Bio has dosed the first patients in the Phase II SIRIUS trial with HBM9378/WIN378 (SKB378), a fully human monoclonal antibody, to treat chronic obstructive pulmonary disease (COPD).
The randomised, global, double-blind, placebo-controlled, dose-finding trial focuses on patients with COPD, a progressive and irreversible lung disease.
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COPD is marked by immune-mediated airway inflammation and persistent airflow obstruction, leading to severe, sudden flare-ups that affect patients’ daily activities and often result in hospitalisations and lasting declines in lung function.
The study is designed to assess the tolerability, safety, pharmacodynamics, and pharmacokinetics of HBM9378/WIN378 in moderate-to-severe COPD patients.
Harbour BioMed founder, chairman and CEO Dr Jingsong Wang said: “We are very pleased to see the continued clinical advancement of HBM9378/WIN378 by our partner Windward Bio with the initiation of the Phase II SIRIUS COPD study.
“This milestone further highlights the potential of HBM9378/WIN378 as a differentiated, ultra-long-acting anti-TSLP antibody for immunological diseases. As one of the originators of this promising molecule and a new investor in Windward Bio, we strongly believe in the potential of HBM9378/WIN378 and Windward Bio’s execution capabilities.
“We look forward to supporting the continued advancement of the programme and ultimately bringing innovative treatment options to patients living with COPD worldwide.”
HBM9378/WIN378 is engineered for half-life extension and effector silencing and is being used in twice-yearly subcutaneous administration.
The molecule has completed a Phase I trial showing extended half-life, a low rate of antidrug antibodies, and favourable safety and tolerability.
Windward Bio holds global rights except for Greater China and some Southeast and West Asian countries.
The molecule is also being evaluated in the POLARIS Phase II/III asthma study, with initial results anticipated in the second half of 2026, and a Phase III asthma study set to begin in the fourth quarter of 2026.
