Hutchison China MediTech has initiated a Phase I study of HMPL-523, its novel spleen tyrosine kinase (Syk) inhibitor, in patients with immune thrombocytopenia (ITP), an autoimmune disorder that can lead to increased risk of bleeding. The first ITP patient was dosed on 12 August 2019 in China.
The study is a randomised, double-blinded, placebo-controlled Phase Ib clinical trial investigating the safety, tolerability, pharmacokinetics and preliminary efficacy of HMPL-523 in adult patients with ITP. The trial comprises a dose escalation stage and a dose expansion stage with the enrolment of nearly 50-60 patients.
Preliminary results of the dose escalation stage in a Phase I study in China of HMPL-523 in patients with relapsed or refractory B-cell lymphomas were presented in 2018. Additionally, a Phase I dose escalation study in Australia in healthy volunteers was completed, showing that HMPL-523 was generally well tolerated.