Sichuan Kelun-BiotechPartner Windward Bio reported positive Phase 2 asthma results for SKB378/WIN378 and initiated the first Phase 3 study.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced that its partner, Windward Bio, reported positive interim results from the Phase 2 portion of the POLARIS-1 trial evaluating twice-yearly dosing of SKB378/WIN378 in asthma, and the first Phase 3 study has been initiated. The interim analysis, conducted on the first 98 of 147 enrolled patients with uncontrolled moderate-to-severe asthma, showed a half-life of up to 75 days, with clinical effects consistent with twice-yearly dosing. SKB378/WIN378 produced significant and sustained effects on FEV1 (up to 174 mL mean increase, placebo-adjusted mean increase up to 256 mL, p=0.033), FeNO, and blood eosinophils, with effects seen as early as Week 2 and sustained through Week 24. The drug was well tolerated, with no treatment-related serious adverse events, withdrawals, or discontinuations; adverse events were balanced between active arms and placebo, with low rates of injection site reactions and anti-drug antibodies. Two twice-yearly doses were selected for the Phase 3 portion of POLARIS-1, and a second Phase 3 trial, POLARIS-2, is planned to begin in the first half of 2027.
Sichuan Kelun-BiotechPartner Windward Bio reported positive Phase 2 asthma results for SKB378/WIN378 and initiated the first Phase 3 study.
Shanghai Henlius Biotech IncWindward Bio reported positive interim Phase 2 results for SKB378/WIN378 in asthma and started Phase 3.