Sotatercept: Additional Phase II data

Data from 22 non-transfusion dependent patients with beta thalassemia in an open-label, international Phase IIa trial showed that subcutaneous sotatercept every 3 weeks led to a maximum hemoglobin increase of >=1 g/dL above baseline in 0% of patients at the 0.1 mg/kg dose, 67% of patients at the 0.3 mg/kg dose, 83% of patients at the 0.5 mg/kg dose and 100% of patients at the 0.75 mg/kg dose. Additionally, sotatercept led to a maximum hemoglobin increase of >=2 g/dL above baseline in 0% of patients at the 0.1 and 0.3 mg/kg doses, 33% of patients at the 0.5 mg/kg dose and 50% of patients at the 0.75 mg/kg dose.

In 10 transfusion dependent patients with beta thalassemia, sotatercept led to a >=20% reduction in transfusion burden in 0% of patients at the 0.1 mg/kg dose, 33% of patients at the 0.3 mg/kg dose, 50% of patients at the 0.5 mg/kg dose and 67% of patients at the 0.75 mg/kg dose. Additionally, sotatercept led to a >=50% reduction in transfusion burden in 0% of patients at the 0.1, 0.3 and 0.5 mg/kg doses and 33% of patients at the 0.75 mg/kg dose. Data were presented at the European Hematology Association meeting in Milan. Interim data from the trial were reported last year (see BioCentury, Dec. 16, 2013). ...