#China #Chengdu #Kelun-Biotech #Windward Bio #SKB378

Kelun-Biotech and Windward Bio Launch Global Phase 2 Asthma Trial

In an exciting development for asthma treatment, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has revealed that its partner, Windward Bio AG, has embarked on a global Phase 2 clinical trial assessing the efficacy of SKB378/WIN378 in patients with asthma. This trial, known as the POLARIS study, aims to provide crucial data on the long-acting dosing of this innovative therapy and its potential benefits for those suffering from this chronic condition.

The SKB378/WIN378 therapy is a fully human monoclonal antibody designed to inhibit the thymic stromal lymphopoietin (TSLP) signaling pathway, which is instrumental in the progression of various immunological diseases, including asthma and chronic obstructive pulmonary disease (COPD). By targeting this pathway, SKB378/WIN378 aims to reduce inflammation and improve overall lung function for asthma patients. The therapy has been engineered for an extended half-life and is administered subcutaneously, allowing for less frequent dosing.

Previous studies conducted in Phase 1 trials have shown that SKB378/WIN378 has a promising safety profile, with a demonstrated ability to minimize the formation of anti-drug antibodies. The initial findings suggest that the treatment is well-tolerated by participants at the highest tested doses.

The Phase 2 POLARIS trial is structured as a double-blind, randomized, placebo-controlled study, which is considered the gold standard in clinical trials for establishing the efficacy and safety of a treatment. This comprehensive design not only ensures an unbiased assessment of the treatment's effects on asthma patients but also helps in understanding the optimal dosing strategy. Results from this trial are anticipated to emerge around mid-2026.

In addition to the ongoing Phase 2 trial for asthma, there are plans to initiate further clinical investigations involving SKB378/WIN378 in COPD, which will hopefully extend to other respiratory indications. In a strategic move earlier this year, the National Medical Products Administration (NMPA) approved an Investigational New Drug (IND) application for this therapy, laying the groundwork for its potential application in treating COPD.

The development of SKB378/WIN378 has been a collaborative effort, originating as a co-development project between Kelun-Biotech and Harbour BioMed, both of which share global rights. Recently, in January 2025, an exclusive license agreement was signed with Windward Bio, enabling them to undertake the global research, development, manufacturing, and commercialization of SKB378/WIN378, excluding territories in Greater China and select Southeast and West Asian countries.

About Kelun-Biotech

Kelun-Biotech is a subsidiary of Kelun Pharmaceutical, focusing on the research and development of innovative biological drugs and small molecules. Their mission is to address critical healthcare needs in China and globally, particularly in the areas of solid tumors, autoimmune diseases, inflammatory conditions, and metabolic diseases. With over 30 innovative drug projects underway, of which three have received marketing approval, Kelun-Biotech is committed to becoming a leader in the global pharmaceutical market.

About Windward Bio

Windward Bio, a clinical-stage biotechnology company, is dedicated to revolutionizing the treatment landscape for advanced immunological conditions. Their lead program, WIN378, represents a potential breakthrough in asthma care, with plans to explore its efficacy in COPD and other respiratory conditions. The company recently secured $200 million in Series A funding, underscoring strong investor confidence in its innovative approach.

As the POLARIS trial progresses, both Kelun-Biotech and Windward Bio are optimistic about the potential impact that SKB378/WIN378 may have on the future of asthma treatment.