Hutchmed has reported that the Phase III ESLIM-01 trial of sovleplenib for the treatment of primary immune thrombocytopenia (ITP) has met the primary and secondary endpoints.
The pivotal, placebo-controlled, double-blinded, randomised study in China enrolled a total of 188 adults with primary ITP, an autoimmune disorder.
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A meaningful and significant increase in durable response rate was observed in the ESLIM-01 group in comparison to the placebo group, demonstrating a primary endpoint.
Secondary endpoints of the trial including response rate and safety were also met.
HUTCHMED chief medical officer Dr Michael Shi said: “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.”
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By GlobalDataBased on these responses, the company plans to submit the new drug application around the end of this year.
China’s National Medical Products Administration also granted breakthrough therapy designation to sovleplenib for this indication.
Sovleplenib is a selective, oral inhibitor targeting spleen tyrosine kinase. It is a component in the Fc receptor and B-cell receptor signalling pathway.
It is also being evaluated in patients with indolent non-Hodgkin’s lymphoma and warm antibody autoimmune haemolytic anaemia.
