NDA for sovleplenib in China as Hutchmed looks to bring this new treatment to ITP patients
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.
In August 2023, HUTCHMED announced that the trial had met its primary endpoint of demonstrating a clinically meaningful and 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 and Hutchmed says full results will be published in due course. Results from the proof of concept study that led to the ESLIM-01 study were published in The Lancet Haematology.
The NMPA granted Breakthrough Therapy designation (BTD) to sovleplenib for the indication studied in ESLIM-01 in January 2022. The NMPA granted this designation to sovleplenib as a new drug that could treat a serious condition for which there are no effective treatment options, and where clinical evidence demonstrates significant advantages over existing therapies.
Weiguo Su isexecutive director, chief executive officer and chief scientific officer of HUTCHMED. “We are pleased to have initiated the rolling submission of an NDA for sovleplenib in China as we look to bring this novel treatment to ITP patients.
"Our submission includes data from the successful Phase III ESLIM-01 trial in China which demonstrated a durable response rate of sovleplenib for patients. There is a significant need for new therapies in adult primary ITP which can significantly impair the quality of life for patients.”
Sovleplenib is a novel, selective inhibitor of Syk for once daily oral administration. Syk is a major component in B-cell receptor and FcR signaling and is an established target for the treatment of multiple subtypes of B-cell lymphomas and autoimmune disorders.
It is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority.
