Chi-Med initiates Phase I study of HMPL-523
Hutchison China MediTech has initiated a Phase I study of HMPL-523, its novel spleen tyrosine kinase, or Syk, inhibitor, in patients with immune thrombocytopenia, or ITP, an autoimmune disorder that can lead to increased risk of bleeding. The first ITP patient was dosed on August 12 in China. The study is a randomized, 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 primary endpoint is the number of patients with any adverse event. The secondary endpoints are maximum plasma concentration, or Cmax, area under the concentration-time curve in a selected time interval, and rate of clinical remission at week 8. The trial is comprised of a dose escalation stage and a dose expansion stage. Approximately 50 to 60 patients will be enrolled.