Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced that its partner Windward Bio has dosed the first patients in the Phase 2 SIRIUS study of SKB378/WIN378 for chronic obstructive pulmonary disease (COPD). The study initiation expands the development of SKB378/WIN378 into a second major respiratory disease, addressing a condition that is the third leading cause of death worldwide. Despite existing therapies, more than 3 million patients with moderate-to-severe COPD remain at high risk of recurrent exacerbations, highlighting the need for new treatments.

Study Details

The SIRIUS study is a global, Phase 2 randomized, double-blind, placebo-controlled, dose-finding trial. It is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SKB378/WIN378 in patients with moderate-to-severe COPD. The drug is a next-generation, fully human monoclonal antibody that inhibits the TSLP ligand, a target validated in immunological diseases such as asthma and COPD.

Development Pipeline

SKB378/WIN378 is currently being evaluated in the Phase 2/3 POLARIS asthma study, with initial Phase 2 data expected in the second half of 2026. The first Phase 3 study in asthma is planned for the fourth quarter of 2026. A Phase 1 trial confirmed an extended half-life suitable for twice-yearly dosing, a low rate of antidrug antibodies, and a safety profile that was well tolerated up to the highest dose tested.

Corporate Background

SKB378/WIN378 originated as a co-development project between Kelun-Biotech and Harbour BioMed, with both parties equally sharing global rights. Windward Bio licensed the global rights, excluding Greater China and several Southeast and West Asian countries, for SKB378/WIN378. Kelun-Biotech is a holding subsidiary of Kelun Pharmaceutical, focusing on innovative biological drugs and small molecule drugs for solid tumors, autoimmune, and metabolic diseases.