Kelun-Biotech's Asthma Drug Shows Promise in Phase 2, Moves to Phase 3
Event summary
- Windward Bio reported positive interim Phase 2 results for SKB378/WIN378 in moderate-to-severe asthma, showing significant improvements in lung function and biomarkers.
- The drug demonstrated a half-life of up to 75 days, supporting twice-yearly dosing with rapid and sustained effects through Week 24.
- No treatment-related serious adverse events were observed, with low rates of injection site reactions and anti-drug antibodies.
- Phase 3 trials have been initiated, with a second Phase 3 study planned for the first half of 2027.
The big picture
Kelun-Biotech's partnership with Windward Bio on SKB378/WIN378 underscores the strategic focus on developing differentiated biologics for respiratory diseases. The positive Phase 2 results and the move to Phase 3 trials position the drug as a potential competitor in the anti-TSLP space, which includes treatments for asthma, COPD, and other immunological diseases. The success of this program could enhance Kelun-Biotech's standing in the global biopharmaceutical market, particularly in addressing unmet clinical needs in respiratory conditions.
What we're watching
- Clinical Efficacy
- Whether the sustained improvements in FEV1, FeNO, and blood eosinophils will translate into reduced asthma exacerbations in Phase 3 trials.
- Regulatory Pathway
- The pace at which regulatory approvals could be achieved given the positive Phase 2 data and the initiation of Phase 3 studies.
- Market Differentiation
- How SKB378/WIN378's unique binding mode and ultra-long-acting profile will position it against existing and emerging anti-TSLP therapies.