Acceleron, Celgene complete enrollment in Phase III of luspatercept in beta-thalassemia

Acceleron Pharma Inc. (NASDAQ:XLRN) and Celgene Corp. (NASDAQ:CELG) completed enrollment of 300 patients with transfusion-dependent beta-thalassemia in the Phase III BELIEVE trial evaluating subcutaneous luspatercept (ACE-536) every 3 weeks for 48 weeks. The companies expect top-line data from the double-blind, placebo-controlled, international trial in mid-2018.

The primary endpoint is the proportion of patients who achieve ≥33% reduction in red blood cell count transfusion burden. Secondary endpoints include the proportion of patients who achieve ≥50% reduction in red blood cell count transfusion burden, mean change in transfusion burden, liver iron concentration, daily iron chelation therapy dose, serum ferritin, total hip and lumbar spine bone mineral density and myocardial iron, quality of life (QOL), hospitalizations, duration of transfusion burden, time to erythroid response, change in number of transfusion events, pharmacokinetics and safety...