Hutchmed’s hope for adults with primary immune thrombocytopenia

The company has announced new drug application (NDA) acceptance in China for its small molecule drug, sovleplenib, and it has also been granted priority review by the China National Medical Products Administration (NMPA).

The drug being given to patients who have received at least one previous therapy, sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase (Syk), being developed for the treatment of hematological malignancies and immune diseases.

ITP is an autoimmune disorder characterized by immunologic destruction of platelets and decreased platelet production. In its research, Hutchmed found that patients with ITP are at increased risk of excessive bleeding and bruising. ITP is also associated with fatigue (reported in up to 39% of adults with ITP) and impaired quality of life.

Adult ITP is a heterogeneous disease that can persist for years, even with the best available care, and treatments are infrequently curative. Even though several treatments with differing mechanisms of action are available, the chronicity of disease continues to be a problem.

Many patients develop resistance to treatment and thereby are prone to relapse. This is why there remains a significant population of patients who have limited sensitivity to currently available agents and need new treatments.

As platelet destruction in ITP is mediated by Syk-dependent phagocytosis of FcγR-bound platelets, Syk inhibition represents a promising approach to the management of ITP.

The NDA is supported by data from ESLIM-01, 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.

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