HUTCHMED Launches Phase II/III ESLIM-02 Trial for Sovleplenib in Chinese wAIHA Patients

HUTCHMED, a biopharmaceutical company, has commenced the registration phase of a Phase II/III clinical trial for sovleplenib, a medication targeting warm antibody autoimmune hemolytic anemia (wAIHA) in China. The decision to proceed to this stage was informed by positive findings from an earlier Phase II study and discussions with the China National Medical Products Administration (NMPA). The trial's primary goal is to evaluate the safety and effectiveness of sovleplenib in adult wAIHA patients, with the main outcome being the number of patients achieving a lasting hemoglobin response by Week 24.

Sovleplenib is an innovative, oral, selective inhibitor that targets spleen tyrosine kinase (Syk), a protein involved in B-cell receptor and Fc receptor signaling, and is a known target for treating B-cell lymphomas and autoimmune disorders. HUTCHMED holds the global rights to this drug. The company is also investigating sovleplenib's potential in treating immune thrombocytopenia (ITP), with a Phase III trial in China having met all its endpoints. The NMPA has granted Breakthrough Therapy designation for ITP and has accepted the New Drug Application for review.

wAIHA is a prevalent autoimmune disorder that leads to red blood cell destruction due to antibodies against red blood cells. The disorder is characterized by an accelerated clearance of antibody-coated red blood cells by macrophages through immunoglobulin Fc receptor signaling, which involves Syk. Inhibition of Syk could potentially treat wAIHA by reducing phagocytosis and antibody production.

HUTCHMED is dedicated to discovering, developing, and commercializing targeted therapies and immunotherapies for cancer and immunological diseases. The company has a global workforce of around 5,000, with a significant team focused on oncology and immunology. They have successfully brought cancer drug candidates from discovery to market, with some now available in the U.S. and China.

The company's ongoing clinical trials and drug development efforts are part of a broader mission to address unmet medical needs and improve patient outcomes for those suffering from serious diseases. HUTCHMED continues to explore the therapeutic potential of its drug candidates, working closely with regulatory authorities and the medical community to advance its pipeline and bring new treatment options to patients worldwide.