HUTCHMED Begins Enrollment for Phase II/III Sovleplenib Trial in China for wAIHA

HUTCHMED, a biopharmaceutical company, has started the registration phase of a Phase II/III clinical trial for sovleplenib in China. This decision was made after successful Phase II results and discussions with China's National Medical Products Administration. The trial aims to evaluate the safety and efficacy of sovleplenib, an investigational oral drug targeting the spleen tyrosine kinase (Syk), for the treatment of warm antibody autoimmune hemolytic anemia (wAIHA), a condition with few treatment options.

The trial, ESLIM-02, is a randomized, double-blind, placebo-controlled study with the primary goal of confirming sovleplenib's impact on adult wAIHA patients. The main measure of success is the percentage of patients showing a sustained hemoglobin response by the 24th week. The study has enrolled 21 participants so far, with an additional 90 expected to join. Leading the research are Dr. Fengkui Zhang, Dr. Bing Han, and Dr. Liansheng Zhang from various medical institutions.

Sovleplenib is being examined for its potential in treating not only wAIHA but also immune thrombocytopenia (ITP). In a Phase III trial for primary ITP, ESLIM-01, sovleplenib met all its endpoints. The NMPA granted the drug a Breakthrough Therapy designation and accepted its New Drug Application for review with priority in January 2024. A similar study in the U.S. is being planned.

wAIHA is an autoimmune disorder characterized by the destruction of red blood cells due to antibodies against them. It is the most prevalent form of autoimmune hemolytic diseases, with a death rate of 8%-11%. The disorder's pathogenic mechanism is believed to involve the clearance of antibody-coated red blood cells by macrophages through the activation of Syk, making it a potential therapeutic target.

HUTCHMED is a commercial-stage company dedicated to developing targeted therapies and immunotherapies for cancer and immunological diseases. It has a global workforce of approximately 5,000, with a significant team focused on oncology and immunology. The company has successfully brought cancer drug candidates to market, with some also available in the U.S.