Sichuan Kelun-Biotech Biopharmaceutical...announced that its partner, Windward Bio, has reported positive interim results from the Phase 2 portion of the POLARIS-1 clinical trial, which evaluates twice-yearly dosing of SKB378/WIN378 in asthma (PRNewswire) - Sep 8, 2026 - "The Phase 2 portion of the study enrolled a total of 147 patients, exceeding the initial enrollment target of 120 patients, with the interim analysis conducted on the first 98 patients. The interim analysis demonstrated the following at Week 24 after a single dose of SKB378/WIN378: Dose-dependent mean increases in FEV1 of up to 174 mL (placebo-adjusted mean increase up to 256 mL, p=0.033). Dose-dependent mean reductions in FeNO of up to 24 ppb (or -43% change, p=0.006). Reductions in mean blood eosinophil count (EOS) of up to 200 cells/µL (or -51% change, p<0.0001). Near maximal effects seen as early as Week 2 and sustained through Week 24....The Phase 3 portion of the study has been initiated by Windward Bio who plans to begin a second Phase 3 study, POLARIS-2, in the first half of 2027. Data from the Phase 2 portion of POLARIS-1 will be presented at an upcoming medical congress."
New P3 trial • P2 data • Trial status • Asthma • Immunology
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