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05 Jan 2023
Admin
News Article

Hutchmed completes patient enrollment in ESLIM-01 phase III trial of sovleplenib to treat primary immune thrombocytopenia

Hutchmed (China) Limited (Hutchmed) announces that it has completed patient enrollment of ESLIM-01, a pivotal phase III clinical trial of sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (ITP) in China. The last patient was enrolled on December 31, 2022. The ESLIM-01 study, initiated in October 2021, is a randomized, double blinded, placebo-controlled phase III clinical trial evaluating the efficacy and safety of sovleplenib in treating adult patients with ITP. The primary endpoint of the study is the durable response rate. Secondary and exploratory endpoints include overall response rate (ORR), incidence of treatment emergent adverse events, and patient quality of life improvement. A total of 188 patients were enrolled. Additional details may be found at clinicaltrials.gov, using identifier NCT05029635. Topline results from the ESLIM-01 trial are expected to be reported in the second half of 2023, followed by submission of results for presentation at an appropriate medical congress. If positive, Hutchmed would initiate plans to apply for marketing authorization of sovleplenib by the China National Medical Products Administration (NMPA). Sovleplenib is a novel, investigational, selective small molecule inhibitor for oral administration targeting the spleen tyrosine kinase, also known as Syk. Syk is a major component in B-cell receptor and Fc receptor signalling and is an established target for the treatment of multiple subtypes of B-cell lymphomas and autoimmune disorders. Hutchmed currently retains all rights to sovleplenib worldwide. In addition to ITP, sovleplenib is also being studied in warm antibody autoimmune haemolytic anaemia (NCT05535933), indolent non-Hodgkin

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