Asthma drug HBM9378 advances to Phase 3 with twice-yearly dosing potential

The interim analysis of the POLARIS-1 study, which enrolled 147 patients, shows that the ultra-long-acting monoclonal antibody effectively targets thymic stromal lymphopoietin (TSLP). By binding to two distinct sites on the protein, the drug blocks signaling pathways that drive airway inflammation. Data from the first 98 participants revealed a half-life of up to 75 days, with clinical benefits manifesting as early as two weeks after administration and persisting through the 24-week mark.

Key efficacy metrics included a placebo-adjusted mean increase in forced expiratory volume (FEV1) of up to 174 mL and significant reductions in blood eosinophil counts and fractional exhaled nitric oxide (FeNO). Safety profiles appeared favorable, with no treatment-related serious adverse events or discontinuations reported among the study cohort. Following these results, Windward Bio has initiated the Phase 3 portion of the study, with a second pivotal trial expected to begin in early 2027.