Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.’s partner, Windward Bio AG has launched its phase 2 POLARIS clinical study, assessing long-acting dosing of SKB378/WIN378 for people living with asthma.
SKB378/WIN378 is a novel, recombinant fully human monoclonal antibody (mAb) that potently binds to the thymic stromal lymphopoietin (TSLP) ligand and inhibits the TSLP mediated signaling pathway by blocking the interaction between TSLP and TSLP receptor. This is a well-validated cytokine that plays a key role in the development and progression of a wide array of immunological conditions, including asthma and chronic obstructive pulmonary disease (COPD) where inhibition has demonstrated benefit in a wide array of inflammatory phenotypes.
SKB378/WIN378 has been engineered to achieve an extended half-life and effector silencing and is subcutaneously administered. SKB378/WIN378 has been studied in a phase 1 trial which confirmed the half-life for extended dosing, demonstrated a low rate of antidrug antibodies, and was safe and well tolerated up to the highest tested dose.
The phase 2 POLARIS trial is a global, randomized, double-blind, placebo-controlled study evaluating the dosing, safety, and efficacy of SKB378/WIN378 in patients with asthma. Initial data is expected in mid-2026. Additional clinical trials are planned with SKB378/WIN378 including in COPD in 2026. In January 2025, an IND application for SKB378/WIN378 for the treatment of COPD was approved by the National Medical Products Administration (NMPA).
SKB378/WIN378 started as a co-development project jointly conducted by the Sichuan Kelun-Biotech and Harbour BioMed (also known as HBM9378), with both parties equally sharing global rights. In January 2025, it was announced that the companies had entered into an exclusive license agreement with Windward Bio, under which they granted Windward Bio an exclusive license for the research, development, manufacturing and commercialization of SKB378/WIN378 globally (excluding Greater China and several Southeast and West Asian countries).
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