Hutchmed has completed participant enrolment in a Phase III ESLIM-01 clinical trial of sovleplenib for primary immune thrombocytopenia (ITP), in China.
Initiated in October 2021, the placebo-controlled, randomised, double blinded Phase III clinical trial has been designed to assess sovleplenib’s safety and efficacy in treating ITP adult patients.
The durable response rate will be the study’s primary endpoint.
Overall response rate (ORR), patient quality of life improvement, and incidence of treatment emergent adverse events are some of the secondary and exploratory endpoints of the trial.
The ESLIM-01 clinical trial enrolled a total of 188 participants.
The company expects to receive topline results from the trial in the second half of this year.
This data is planned to be submitted for presentation at an appropriate medical congress.
Hutchmed then intends to seek marketing authorisation from the China National Medical Products Administration (NMPA) for sovleplenib.
Sovleplenib is a novel, investigational, selective small molecule inhibitor for oral administration targeting the spleen tyrosine kinase (Syk).
Syk is said to be a major component in B-cell receptor and Fc receptor signalling. It is an established target for treating multiple subtypes of B-cell lymphomas and autoimmune disorders.
The company stated that the small molecule inhibitor is also being investigated in various cancers including indolent non-Hodgkin’s lymphoma, autoimmune hemolytic anemia, and multiple subtypes of B-cell malignancies in China, Europe, and the US.
In November last year, Hutchmed reported positive data from the Phase III FRUTIGA study of fruquintinib for the treatment of advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma.