Hutchmed announces phase 3 trial met primary endpoint for primary immune thrombocytopenia treatment
Betsy Goodfellow | August 21, 2023 | News story | Research and Development | HUTCHMED, Haematology, clinical trial, sovleplenib, thrombocytopenia
Hutchmed has announced that its phase 3 trial ESLIM-01 trial assessing the use of sovleplenib has met its primary endpoint of durable response rate and all secondary endpoints in adult patients with primary immune thrombocytopenia (ITP) in China.
China’s National Medical Products Administration (NMPA) granted the drug Breakthrough Therapy Designation (BTD) in January 2022, meaning the drug could treat serious conditions where there are no effective treatment option and where clinical evidence demonstrates an advantage over existing therapies.
The trial included 188 adult patients with primary ITP who had received at least one prior therapy and met its primary endpoint of demonstrating a clinically meaningful and statistically significant increase in durable response rate in patients treated with sovelplenib compared to placebo. Full results are expected to be published at an upcoming conference.
Dr Michael Shi, chief medical officer at Hutchmed, commented: “Sovleplenib offers a potential new treatment for patients with chronic adult primary ITP who have received at least one prior therapy, a heterogeneous disease that can persist for years and where there remains a significant need for new treatments. We are very pleased to see the positive outcomes of the ESLIM-01 study and would like to thank the patients, their families, and the healthcare professionals who participated in this study and helped reach this achievement.”
Hutchmed is intending to submit its New Drug Application towards the end of 2023.
Betsy Goodfellow
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