Harbour BioMed's Asthma Drug HBM9378/WIN378 Advances to Phase 3 After Strong Phase 2 Results
Event summary
- HBM9378/WIN378 demonstrated a half-life of up to 75 days, supporting twice-yearly dosing in asthma patients.
- Phase 2 results showed significant improvements in lung function (FEV1) and reductions in inflammation biomarkers (FeNO, eosinophils).
- No treatment-related serious adverse events were reported, with low immunogenicity and favorable safety profile.
- Phase 3 trials have begun, with a second study (POLARIS-2) planned for H1 2027.
The big picture
Harbour BioMed's ultra-long-acting antibody HBM9378/WIN378 represents a strategic push into the competitive immunology space, targeting TSLP—a clinically validated pathway for asthma and other inflammatory diseases. The drug's extended half-life and twice-yearly dosing could reduce treatment burden, addressing an unmet need in severe asthma management. The Phase 3 initiation marks a critical milestone in validating the molecule's commercial potential.
What we're watching
- Clinical Efficacy
- Whether the sustained improvements in lung function and inflammation biomarkers will translate into reduced asthma exacerbations in Phase 3.
- Regulatory Pathway
- The pace at which HBM9378/WIN378 can secure approvals, given the strong Phase 2 data and favorable safety profile.
- Market Differentiation
- How Harbour BioMed and Windward Bio position HBM9378/WIN378 against existing TSLP inhibitors in asthma and potential expansion into other respiratory diseases.