China-based biopharmaceutical company HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that the pivotal Phase III trial ESLIM-01 evaluating the investigational use of sovleplenib has successfully met its primary endpoint of durable response rate and all secondary endpoints in adult patients with primary immune thrombocytopenia (ITP). The trial was conducted in China, and HutchMed plans to submit a New Drug Application (NDA) around the end of 2023.
Sovleplenib’s Mechanism of Action and Development
Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase (Syk), which is under development as a treatment for hematological malignancies and autoimmune diseases. Syk plays a significant role in B-cell receptor and Fc receptor (FcR) signaling and is an established target for the treatment of multiple subtypes of B-cell lymphomas and autoimmune disorders, including ITP. In January 2022, China’s National Medical Products Administration awarded the molecule breakthrough therapy designation for the indication studied in ESLIM-01.
ESLIM-01 Trial Design and Results
ESLIM-01 is a randomized, double-blinded, placebo-controlled Phase III study in China involving 188 adult patients with primary ITP who have received at least one prior line of standard therapy. Enrollment for the trial was completed in December 2022. The trial demonstrated a clinically meaningful and statistically significant increase in durable response rate in patients treated with sovleplenib compared to those treated with placebo, meeting its primary endpoint. Secondary endpoints, including response rate and safety, were also successfully met. Full results of the trial will be submitted for presentation at an upcoming scientific conference.-Fineline Info & Tech
