Windward Bio Advances Asthma Therapy with Twice-Yearly Dosing

The POLARIS-1 clinical trial, which enrolled 147 patients, showed that the treatment rapidly improved lung function and reduced inflammatory biomarkers. Interim analysis of the first 98 participants revealed a placebo-adjusted increase in FEV1 of up to 256 mL, alongside substantial reductions in fractional exhaled nitric oxide and blood eosinophils. These effects remained consistent through the 24-week mark, suggesting that the therapy could offer a viable alternative to more frequent treatment regimens.

Safety data from the interim analysis were favorable, with no treatment-related serious adverse events or discontinuations reported. Less than 1% of the cohort experienced injection site reactions, and while 2% developed anti-drug antibodies, these did not interfere with the drug's pharmacological activity. The candidate functions by inhibiting thymic stromal lymphopoietin (TSLP) through a unique dual-binding mechanism that blocks interaction with both primary cell-surface co-receptors.

Following these results, Windward Bio has initiated the Phase 3 portion of the study to evaluate two twice-yearly dosing schedules for severe asthma patients. A second pivotal trial, POLARIS-2, is scheduled to begin in the first half of 2027. Kelun-Biotech CEO Dr. Michael Ge noted that the drug’s ability to balance potency with a reduced treatment burden addresses a significant gap in current respiratory care.