HBM Holdings Limited (HBM) and development partner Windward Bio AG have initiated patient dosing in the Phase II SIRIUS trial of HBM9378/WIN378 (also known as SKB378), marking a key milestone in the molecule’s clinical progression and expanding its indication portfolio beyond asthma to chronic obstructive pulmonary disease (COPD).
SIRIUS DESIGN • Study type: Global, randomized, double-blind, placebo-controlled, dose-finding Phase II trial. • Objectives: Assess safety, tolerability, pharmacokinetics and pharmacodynamics in patients with moderate-to-severe COPD.
PIPELINE CONTEXT • HBM9378/WIN378 is already under evaluation in the POLARIS Phase II/III asthma program, with initial Phase II data targeted for the second half of 2026. • Windward Bio plans to launch the first Phase III asthma study in the fourth quarter of 2026. • Initiation of SIRIUS positions COPD as the second major respiratory indication for the antibody.
ASSET PROFILE • Modality: Fully human monoclonal antibody that potently inhibits thymic stromal lymphopoietin (TSLP). • Engineering: Half-life extension and silenced effector function enable twice-yearly subcutaneous dosing. • Phase I data: Demonstrated extended half-life, low anti-drug antibody incidence, and a favorable safety profile up to the highest dose tested.
PARTNERSHIP STRUCTURE • Windward Bio holds global rights outside Greater China and several Southeast and West Asian markets; Harbour BioMed and Kelun-Biotech retain rights in those excluded territories.
STRATEGIC IMPLICATION The SIRIUS trial launch underscores HBM’s strategy to build a differentiated respiratory franchise around ultra long-acting biologics targeting validated immunological pathways.
Cautionary note: The company states there is no guarantee of successful development or commercialization of HBM9378/WIN378, and advises shareholders and investors to exercise prudence when dealing in HBM shares.
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