Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases, today announced that its collaboration partner, Celgene, has initiated a phase 2 clinical trial of sotatercept in patients with end stage renal disease on hemodialysis. Sotatercept is a novel and first-in-class activin type IIA receptor (ActRIIA) fusion protein that acts during late-stage erythropoiesis (red blood cell production) to increase the production of mature red blood cells into circulation. Acceleron will receive a $7 million milestone payment from Celgene for the achievement of this event and is also eligible to receive future development, regulatory and commercial milestones of up to $360 million for the sotatercept program.
“In previous clinical studies, sotatercept has shown encouraging activity by increasing red blood cells as well as bone mass in patients,” said Matthew Sherman, M.D., Chief Medical Officer at Acceleron. “We believe that the distinct profile of sotatercept could benefit many patients, including those who have end stage renal disease, the most advanced stage of chronic kidney disease. We look forward to the ongoing development of this promising protein therapeutic candidate, which is also being studied in phase 2 trials in several rare hematologic diseases, including beta-thalassemia and myelodysplastic syndromes.”
About the Phase 2 Clinical Trial
The phase 2 clinical trial in patients with end stage renal disease (ESRD) who are on hemodialysis is designed as a two-part study to assess the safety and efficacy of sotatercept as a therapy to treat anemia and potentially to control the adverse manifestations of chronic kidney disease mineral and bone disorder (CKD-MBD). Patients in both parts of the study must first be on a stable dose of an erythropoiesis stimulating agent (ESA) to maintain hemoglobin levels and will then be switched to treatment with sotatercept after an ESA treatment free period of approximately five days.