17th Jun 2024 10:32
(Alliance News) - Hutchmed (China) Ltd on Monday said its phase 3 trial of sovleplenib showed "consistent benefits" in adults with autoimmune disorder primary immune thrombocytopenia or ITP.
The Hong Kong-headquartered biopharmaceutical company said results from the trial, named ESLIM-01, were recently published in The Lancet Haematology.
Sovleplenib, or HMPL-523, is a selective oral inhibitor targeting the spleen tyrosine kinase or SYK enzyme, to treat hematological malignancies and immune diseases. ITP is a rare autoimmune disorder which prevents the blood from clotting properly as the immune system destroys the necessary platelets.
"The ESLIM-01 trial results published by The Lancet Haematology suggest that sovleplenib could be a potential treatment option for patients with ITP who received at least one prior therapy," Hutchmed noted.
Hutchmed said the double-blind study was conducted in China, in 188 adult patients with primary ITP. It met its primary endpoint with a 48.4% durable response rate with sovleplenib compared to 0% with a placebo. Overall response rates reached 70.6% at zero to 24 weeks on sovleplenib versus 16.1% for the placebo group.
"The study demonstrated a clinically meaningful early and sustained durable platelet response in patients with primary ITP, with a tolerable safety profile and improvement in quality of life," Hutchmed added.
The company also noted "subgroup analyses demonstrating consistent benefits regardless of prior lines of therapies". It said the data further supports the China National Medical Products Administration's decision to accept sovleplenib's new drug application for priority review in January.
Hutchmed is also planning a dose-finding study of sovleplenib in the US, and in May commenced registration in China for a phase 2/3 trial in adult patients with warm antibody autoimmune hemolytic anemia.
Hutchmed retains all rights to sovleplenib worldwide.
Shares in Hutchmed were down 3.3% at 283.20 pence in London on Monday morning.
By Emma Curzon, Alliance News reporter
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