Hutchmed China completes enrolment for solveplenib clinical trial

Hutchmed China announced on Tuesday that it has completed patient enrollment for ‘ESLIM-01’, a pivotal phase 3 clinical trial of sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (ITP) in China.

The AIM-traded firm said the last patient was enrolled on 31 December.

It said the ESLIM-01 study, initiated in October 2021, is a randomised, double-blinded, placebo-controlled phase 3 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, incidence of treatment emergent adverse events, and patient quality of life improvement,” the board said in its statement.

Hutchmed said a total of 188 patients were enrolled.

“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).”

At 1551 GMT, shares in Hutchmed China were up 5.28% at 277.95p.

Reporting by Josh White for Sharecast.com.