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China Phase III Results Boost Global Prospects For HUTCHMED ITP Drug

 
• By Dexter Jie Yan

The Phase III ESLIM-01 study with HUTCHMED’s Syk inhibitor sovleplenib met its primary endpoint, demonstrating a 48.4% durable response rate for chronic immune thrombocytopenia, significantly higher than placebo. Global development appears to be accelerating and a multinational dose-finding Phase Ib study has also been initiated.

Blood disorder
Immune thrombocytopenia is a rare autoimmune blood disorder • Source: Shutterstock

HUTCHMED (China) Limited looks set to step up its first major effort to gain a foothold in the US autoimmune space after positive results from the China-only Phase III ESLIM-01 clinical study with sovleplenib in heavily pretreated patients with chronic primary immune thrombocytopenia (ITP), a rare autoimmune blood disorder. 

Key Takeaways

  • Results from the Phase III ESLIM-01 study with HUTCHMED'S sovleplenib, a novel spleen tyrosine kinase (Syk) inhibitor, show a significantly higher durable response rate than placebo in heavily pretreated patients with chronic primary immune thrombocytopenia.

  • Efficacy outcomes were less impressive in a small group the patients who had undergone prior splenectomy

Clinical outcomes from the 188-patient study showed the novel spleen tyrosine kinase (Syk) inhibitor met the primary endpoint of a significantly higher durable response rate than placebo, both in the intent-to-treat (ITT) population and patients who had received second-line therapy with thrombopoietin and

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