HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

Phase 2/3 Active not recruiting 111 enrolled Hutchmed

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Phase II Study: To evaluate the safety and preliminary efficacy of HMPL-523 in adult patients with wAIHA. Phase III Study(Part A): Confirmation of Efficacy safety and of HMPL-523 in adult patients with wAIHA. Phase III Study (Part B): To further evaluate the long-term safety and tolerability of HMPL-523 in adult patients with wAIHA.

Timeline

Start: 2022-09-30
Primary completion: 2025-11-25
Completion: 2026-11

Outcome

Met primary endpoint

release “Positive ESLIM-02 Phase III wAIHA results for sovleplenib meeting primary endpoint of durable response rate within 24 weeks.” hutch-med.com ↗

Publications

Zhao X, Sun J, Zhang Z, Chen M, Gong T, He G, Li Y, Liu H, Li F, Li X, Zhou H, Wang X, Hong M, Lei L, Yin H, Luo X, Li Y, Fan S, Guo X, Shi MM, Su W, Zhang L, Han B, Zhang F. Sovleplenib in patients with primary or secondary warm autoimmune haemolytic anaemia: results from phase 2 of a randomised, double-blind, placebo-controlled, phase 2/3 study. Lancet Haematol. 2025 Feb;12(2):e97-e108. doi: 10.1016/S2352-3026(24)00344-2. Epub 2025 Jan 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sovleplenib	Small molecule	300 mg	Oral