HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced the initiation of the Phase II/III ESLIM-02 study for its investigational drug, sovleplenib, in patients with warm antibody autoimmune hemolytic anemia (wAIHA) in China. The ESLIM-02 trial is a randomized, double-blind, placebo-controlled study aimed at confirming the safety and efficacy of sovleplenib in adult patients. The primary endpoint is the proportion of patients achieving a durable hemoglobin (Hb) response by Week 24. To date, 21 patients have been enrolled, with plans to enroll approximately 90 more. This development follows encouraging data from the proof-of-concept Phase II stage and subsequent consultations with the National Medical Products Administration (NMPA). Positive results from this trial could support a future New Drug Application (NDA) filing.
Sovleplenib is a novel oral small-molecule inhibitor selectively targeting spleen tyrosine kinase (Syk), a key player in B-cell receptor and Fc receptor signaling. Syk is a recognized target for treating various subtypes of B-cell lymphomas and autoimmune disorders. In addition to wAIHA, sovleplenib is also under investigation for immune thrombocytopenia (ITP), where the Phase III study has successfully met all endpoints, earning breakthrough therapy designation (BTD) and priority review status in China.- Flcube.com
