On September 24, global clinical trial registry data revealed that Sanofi SA (SNY.US) has advanced its TSLP/IL-13 dual antibody Lunsekimig (SAR443765) to Phase II/III development, launching two Phase II/III clinical studies (THESEUS and PERSEPHONE) targeting chronic obstructive pulmonary disease (COPD). The two studies plan to enroll 1,884 patients and aim to evaluate the efficacy and safety of Lunsekimig (at two dose levels, administered subcutaneously) compared to placebo in treating adult patients with poorly controlled eosinophilic phenotype COPD. The primary endpoint of the studies is the annualized rate of moderate to severe COPD exacerbations from baseline to week 48.

Previously, Sanofi SA had announced Phase Ib proof-of-concept study data for Lunsekimig in asthma treatment. The data demonstrated that asthma patients showed a significant reduction in fractional exhaled nitric oxide (FENO) after 28 days of treatment with 400mg Lunsekimig compared to baseline, with a reduction of 40.9ppb versus placebo group (p<0.0001). Additionally, patients' Type 2 inflammatory response biomarker levels were also significantly reduced.