SKB BIO (06990.HK): Positive Phase II Interim Results for SKB378/WIN378 in Asthma; Phase III Initiated

NewTimeSpace News: On 8 September 2028, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (stock code: 06990) issued a voluntary announcement stating that its collaborator Windward Bio AG had reported positive interim results from the Phase II part of the POLARIS-1 clinical trial of SKB378/WIN378, a fully human ultra-long-acting monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), for the treatment of asthma, and that the Phase III part of POLARIS-1 had also been initiated.

According to the announcement, POLARIS-1 (NCT07120503) is a seamless global Phase II/III study conducted by Windward Bio. The Phase II part was a 48-week randomised, double-blind study that enrolled 147 adult patients with uncontrolled asthma, exceeding the initial target of 120 patients, with the interim analysis based on data from the first 98 patients. Interim results showed that at week 24 after a single dose, forced expiratory volume in one second (FEV1) increased in a dose-dependent manner by up to 176 mL (up to 256 mL placebo-adjusted mean increase, p=0.033); fractional exhaled nitric oxide (FeNO) decreased by up to 24 ppb (43% reduction, p=0.006); and blood eosinophil count (EOS) decreased by up to 200 cells/µL (51% reduction, p<0.0001). Effects approached near-maximum levels as early as week 2 and were sustained through week 24, and the interim analysis indicated a half-life of up to 75 days, supporting a twice-yearly dosing regimen.

SKB378/WIN378 demonstrated favourable tolerability and safety, with no treatment-related serious adverse events, discontinuations or withdrawals observed as of the data cutoff date, an injection site reaction rate below 1% and an anti-drug antibody rate of 2%. The molecule is the only investigational drug known to date that blocks TSLP signalling through dual-site binding, and was originally co-developed by the company and HBM Holdings Limited, with both parties sharing global rights. Windward Bio has obtained global rights to the molecule (excluding Greater China and certain Southeast Asian and West Asian countries). The Phase III part adopts two twice-yearly dosing regimens, and Windward Bio plans to initiate a second Phase III study, POLARIS-2, in the first half of 2027.

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