HBM HOLDINGS-B (ASX: 02142) has announced that its partner, Windward Bio AG, has dosed the first patients in the Phase II SIRIUS study evaluating HBM9378, also known as WIN378 or SKB378, for the treatment of chronic obstructive pulmonary disease (COPD).
The drug candidate is a fully human, ultra-long-acting, targeted thymic stromal lymphopoietin (TSLP) antibody. The SIRIUS trial is a global, randomized, double-blind, placebo-controlled, dose-ranging Phase II study designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of HBM9378 in patients with moderate-to-severe COPD.
HBM9378 is also being evaluated in Windward Bio's Phase II/III POLARIS study for asthma, with initial Phase II data expected in the second half of 2026. Windward Bio anticipates that the first Phase III asthma study for HBM9378 will commence in the fourth quarter of 2026.
The initiation of the SIRIUS COPD study expands the clinical development of HBM9378 into COPD as a second major respiratory disease. The board of HBM HOLDINGS-B believes that the start of this study marks continued clinical progress for HBM9378 and provides further evidence of the molecule's potential as a differentiated, ultra-long-acting targeted TSLP antibody for treating immune-mediated diseases.
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