BioCentury
ARTICLE | Clinical News

Sotatercept: Additional Phase IIa data

May 5, 2014 7:00 AM UTC

Additional interim data from 18 evaluable patients with ESRD on hemodialysis in the 2-part, double-blind Phase IIa REN-001 trial showed that 37% of patients receiving 0.3 mg/kg subcutaneous sotatercept (n=8) and 40% of patients receiving 0.5 mg/kg subcutaneous sotatercept (n=5) achieved a target hemoglobin increase of >=1 g/dL during the first 28-day cycle vs. 20% for placebo (n=5). Additionally, 13% of patients receiving 0.3 mg/kg sotatercept and 0% of patients receiving 0.5 mg/kg sotatercept required rescue therapy with erythropoietin therapy during the first cycle vs. 40% for placebo. Patients in the first part of the trial received a single dose of 0.1 mg/kg sotatercept. In the second part of the trial, cohorts of up to 12 patients each will receive placebo or 0.3, 0.5 or 0.7 mg/kg sotatercept once every 4 weeks for up to 8 cycles or a 0.7 mg/kg loading dose of sotatercept followed by 0.4 mg/kg sotatercept. The trial will enroll up to 56 patients. Data were presented at the National Kidney Foundation meeting in Las Vegas. Interim data from the trial were reported in March (see BioCentury, March 24). ...