A phase 3 trial of Hutchmed’s autoimmune disease candidate sovleplenib has hit ts primary endpoint, delivering a boost to an asset that was held up by quality issues in another indication.
Hong Kong-based Hutchmed is developing its Syk inhibitor in immune thrombocytopenia (ITP) and warm antibody autoimmune hemolytic anemia (wAIHA).
The breach of an impurity limit delayed an attempt to win approval in ITP in China, forcing the biotech to perform chemistry, manufacturing and controls work in preparation for resubmission in the first half of 2026.
Hutchmed has continued to test sovleplenib in wAIHA in parallel, culminating in the delivery of data from a Chinese phase 3 trial that could lead to approval of the asset in the autoimmune disease.
The wAIHA study met its primary endpoint of durable hemoglobin response rate within weeks five to 24 of treatment.
The biotech is yet to share its pivotal data.
In the phase 2 part of the trial, Hutchmed reported an overall response rate of 43.8% in the sovleplenib cohort in the first eight weeks, compared to 0% on placebo.
The overall response rate across 24 weeks of daily oral treatment with sovleplenib was 66.7%.
