Kelun-Biotech Partners with Windward Bio for Asthma Trial
Kelun-Biotech and Windward Bio Launch Phase 2 Asthma Trial
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKEX: 6990) has teamed up with Windward Bio AG to initiate the Phase 2 POLARIS clinical study. This important study focuses on SKB378/WIN378, a promising treatment for individuals living with asthma, targeting long-acting dosing.
What is SKB378/WIN378?
SKB378/WIN378 is a recombinant fully human monoclonal antibody designed to effectively bind to the thymic stromal lymphopoietin (TSLP) ligand. This unique mechanism inhibits the TSLP mediated signaling pathway by obstructing the interaction between TSLP and its receptor. TSLP is a well-established cytokine that contributes to various immunological disorders, including asthma and chronic obstructive pulmonary disease (COPD). Its inhibition can lead to substantial benefits across different inflammatory conditions.
Details of the POLARIS Trial
The Phase 2 POLARIS trial is a global, randomized, double-blind placebo-controlled study aimed at accurately evaluating the safety, efficacy, and dosing of SKB378/WIN378 in asthma patients. The study is designed to provide critical insights into the potential effectiveness of this treatment, with initial results anticipated by mid-2026. There are also plans for further clinical investigations involving SKB378/WIN378 in COPD, expected to commence shortly thereafter.
Previous Success and Future Prospects
Earlier studies in a Phase 1 trial confirmed that SKB378/WIN378 possesses an extended half-life beneficial for dosing schedules, revealed a low incidence of antidrug antibodies, and demonstrated safety at the highest doses analyzed. This lays a solid foundation for the ongoing Phase 2 study and future research endeavors.
Co-development and Licensing Agreement
Initially, SKB378/WIN378 began as a collaborative project between Kelun-Biotech and Harbour BioMed. Both companies have been operationally engaged to share global rights equally. Recently, they formed an exclusive licensing agreement with Windward Bio, empowering Windward to carry out research, development, manufacturing, and commercialization of the treatment worldwide, explicitly excluding Greater China and select Southeast and West Asian territories.
About Kelun-Biotech
Kelun-Biotech (6990.HK) operates as a subsidiary of Kelun Pharmaceutical (002422.SZ), focusing on innovative drug research and development, manufacturing, and commercialization. The company is dedicated to addressing critical medical challenges, concentrating on solid tumors, autoimmune diseases, and metabolic disorders among others. Currently, it has over 30 active innovative drug projects, including three that have received marketing approval and many more at various development stages.
About Windward Bio
Windward Bio is a developing biotechnology company committed to improving the lives of individuals with severe immunological conditions. Their lead candidate, WIN378, is in the Phase 2 stage for asthma treatment, demonstrating their commitment to discovering effective solutions. Windward Bio plans to expand its clinical studies of WIN378 to further address COPD and other respiratory challenges. Supported by a $200 million Series A funding, Windward is poised to make significant advancements in the field.
Frequently Asked Questions
What is the purpose of the Phase 2 POLARIS trial?
The POLARIS trial aims to evaluate the dosing, safety, and efficacy of SKB378/WIN378 in asthma patients.
What are the mechanisms of action for SKB378/WIN378?
SKB378/WIN378 binds to the TSLP ligand, inhibiting the related signaling pathways that contribute to asthma and other inflammatory diseases.
When can initial trial results be expected?
Initial data from the POLARIS trial is expected by mid-2026.
Are there plans to study SKB378/WIN378 in diseases other than asthma?
Yes, there are plans to investigate SKB378/WIN378 in additional trials for COPD and other respiratory conditions.
Who is leading the clinical development of SKB378/WIN378?
The clinical development is a collaboration primarily between Kelun-Biotech and Windward Bio, following a licensing agreement with Harbour BioMed.
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