The company announced yesterday (August 21) that its pivotal phase 2 trial called Eslim-01 evaluating the investigational use of sovleplenib has met its primary endpoint of durable response rate and all secondary endpoints in adult patients with ITP.
Primary immune thrombocytopenia (ITP) is a medical term for an immune condition causing an immunologic destruction of platelets (thrombocytopenia) and bruising (purpura). Patients with the condition are at increased risk of excessive bleeding as well as bruising. It affects quality of life and is associated with fatigue.
Adult ITP is a heterogeneous disease that can persist for years, even with best available care, and treatments are infrequently curative. Despite availability of several treatments with differing mechanisms of action, chronicity of disease continues to be a problem.
Hutchmed found in its research that many patients develop resistance to treatment and thereby are prone to relapse. This is why, it says, there remains a significant population of patients who have limited sensitivity to currently available agents and are in need of new treatments.
The company is now planning to submit the New Drug Application (NDA) for the treatment around the end of 2023.
The National Medical Products Administration of China (NMPA) granted Breakthrough Therapy Designation (BTD) to sovleplenib for the indication studied in Eslim-01 in January 2022.
The Sovleplenib NDA may be considered for priority review for its use in ITP after the NMPA granted this designation as a new drug that could treat a serious for which there are no effective treatment options, and where, Hutchmed says, clinical evidence demonstrates significant advantages over existing therapies.
Primary ITP
Eslim-01 is a randomized, double-blinded, placebo-controlled phase 3 trial in China of sovleplenib in 188 adult patients with primary ITP who have received at least one prior line of standard therapy. Enrollment was completed in December 2022.
Michael Shi, chief medical officer of Hutchmed, 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.”
The trial met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in durable response rate in patients treated with sovleplenib as compared to patients treated with placebo. Secondary endpoints including response rate and safety were also met. Full results will be submitted for presentation at an upcoming scientific conference.
Ren-Chi Yang is a medicine doctor at the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, who served as the Eslim-01 co-leading principal investigator and steering committee member.
He said: “By meeting the primary and all the secondary endpoints in this study while demonstrating a good level of tolerability and once daily oral dosing, I am optimistic that sovleplenib may be a potential choice to help ITP patients.”
Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase (Syk) for the treatment of hematological malignancies and immune diseases. Syk is a component in Fc receptor (FcR) and B-cell receptor signaling pathway. ITP is an autoimmune disorder that can lead to increased risk of bleeding. Encouraging proof of concept data was presented at American Society of Hematology 2021 and published in The Lancet Haematology in June 2023.
Professor Yu Hu is a doctor at the Union Hospital, Tongji Medical College, Huazhong University of Science and Technology and co-Leading principal investigator. He added: “Many patients with recurrent or refractory ITP feel burdened by their disease in their daily lives and by the management of their current medications. I welcome the opportunity to offer my patients another treatment option to live better with their disease.”
