Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced the completion of patient enrollment in the ESLIM – 01 study, a pivotal Phase III trial assessing the efficacy and safety of sovleplenib in treating adult patients with primary immune thrombocytopenia (ITP) in China. This marks a significant milestone in the development of sovleplenib, a novel, investigational, selective small – molecule inhibitor targeting spleen tyrosine kinase (Syk).
About Sovleplenib and Syk
Sovleplenib is designed to inhibit Syk, a key enzyme in B – cell receptor and Fc receptor signaling pathways. Syk is an established target for the treatment of multiple subtypes of B – cell lymphomas and autoimmune disorders. By targeting Syk, sovleplenib aims to provide a new therapeutic option for patients with ITP, a condition characterized by low platelet counts and an increased risk of bleeding.
Study Design and Endpoints
The primary endpoint of the ESLIM – 01 study is durable response rate, with secondary and exploratory endpoints including overall response rate (ORR), the incidence of treatment – emergent adverse events, and improvements in patient quality of life. A total of 188 patients have been enrolled in the trial (see NCT05029635). Topline results from the ESLIM – 01 trial are expected in the second half of 2023. If the results are positive, HutchMed plans to apply for marketing authorization for sovleplenib with the China National Medical Products Administration (NMPA).
Global Development and Future Plans
HutchMed currently retains all rights to sovleplenib worldwide. In addition to ITP, sovleplenib is also being studied in other indications, including warm antibody autoimmune hemolytic anemia (NCT05535933), indolent non – Hodgkin’s lymphoma, and multiple subtypes of B – cell malignancies in China, the US, and Europe (NCT02857998; NCT03779113). These ongoing trials highlight HutchMed’s commitment to advancing sovleplenib as a potential treatment for a range of autoimmune and hematologic disorders.-Fineline Info & Tech
