Pharma Focus Asia

HUTCHMED Launches Registration Phase for Sovleplenib Trial Targeting Warm Antibody Autoimmune Hemolytic Anemia in China

Friday, March 22, 2024

HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) made an announcement today regarding the initiation of the registration stage for the Phase II/III clinical trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (“wAIHA”) in China.

This development comes after encouraging results from the proof-of-concept Phase II part of the trial and subsequent consultations with the China National Medical Products Administration (“NMPA”). Positive outcomes from this trial could potentially support a future New Drug Application (“NDA”) submission. wAIHA is an autoimmune disorder that often leads to anemia and currently has limited treatment options. The Phase III trial saw its first patient receiving the initial dose on March 20, 2024.

The trial, known as ESLIM-02, is a randomized, double-blind, placebo-controlled Phase II/III study. Its primary objective during the registration stage is to confirm the safety and efficacy of sovleplenib in adult patients with wAIHA. The key endpoint for this study is the proportion of patients achieving a sustained hemoglobin (Hb) response by Week 24. Currently, 21 patients have been enrolled, and around 90 more are expected to be enrolled in this registration phase. The lead principal investigators for this trial are Dr. Fengkui Zhang of the Chinese Academy of Medical Sciences Blood Diseases Hospital, Dr. Bing Han of the Chinese Academy of Medical Sciences Peking Union Medical College Hospital, and Dr. Liansheng Zhang of Lanzhou University Second Hospital. Further details can be found on under the identifier NCT05535933.

Sovleplenib is a novel, investigational, selective small molecule inhibitor administered orally, targeting the spleen tyrosine kinase, also known as Syk. Syk plays a crucial role in B-cell receptor and Fc receptor signaling and is a recognized target for treating various B-cell lymphomas and autoimmune disorders. HUTCHMED currently holds all rights to sovleplenib globally.

Besides wAIHA, sovleplenib is also being investigated for immune thrombocytopenia (“ITP”). ESLIM-01 (NCT05029635) is a Phase III trial in China, a randomized, double-blind, placebo-controlled study evaluating sovleplenib in patients with primary ITP, which successfully met all its endpoints. ITP is an autoimmune disorder associated with an elevated risk of bleeding. The NMPA granted Breakthrough Therapy designation for this indication and accepted the New Drug Application (NDA) for review with Priority Review status in January 2024. A dose-finding study in the U.S. is also in the planning stages (NCT06291415).

AIHA is an autoimmune disorder characterized by the destruction of red blood cells (“RBCs”) due to the production of antibodies against RBCs. The incidence of AIHA is estimated to be 0.8-3.0/100,000 adults per year, with a prevalence of approximately 17 per 100,000 adults and a mortality rate of 8%-11%. wAIHA is the most prevalent form of autoimmune hemolytic diseases, accounting for about 75-80% of all adult AIHA cases.

The accelerated clearance of antibody-coated RBCs by Fc receptor (“FcR”) bearing macrophages is believed to be the pathogenic mechanism in wAIHA. This process involves the activation of Syk, a signaling subunit associated with FcR, which, upon phosphorylation following receptor binding, leads to the recruitment and activation of Syk. Activated Syk then mediates downstream signaling of the activated FcRs in phagocytic cells, resulting in the phagocytosis of RBCs. Additionally, activation of Syk through the B-cell receptor facilitates the activation and differentiation of B-lymphocytes into antibody-secreting plasma cells. Therefore, inhibition of Syk may hold promise in wAIHA treatment by inhibiting phagocytosis and reducing antibody production.



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