Amgen's Kidney Drug Hits Endpoints In Phase 3 Trial

Amgen announced that the Phase III trial of its investigational drug AMG 416 for secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) met all of its primary and secondary endpoints.

AMG 416 (previously known as velcalcetide) is a novel, intravenously-administered calcimimetic agent under clinical development for the treatment of SHPT in CKD patients who are receiving hemodialysis. The drug works by binding to and inducing the parathyroid’s calcium-sensing receptor to action, leading to a decrease in parathyroid hormone (PTH) levels. The company acquired AMG 416 as part of its $315M dollar purchase of KAI Pharmaceuticals in July 2012.

The drug was assessed in a 26-week, double blind, placebo controlled, randomized study for efficacy and safety in 515 patients. The primary endpoint of the trial was the proportion of patients who experienced significant reduction from baseline PTH during the Efficacy Assessment Phase (EAP) between weeks 20 and 27. Secondary trial endpoints included percent change from baseline during EAP in serum phosphorus (P) concentration and corrected calcium. The drug achieved statistically significant results in all endpoints. The results are the first to be reported from the Phase III program for AMG 416 since its acquisition.

Sean E. Harper, EVP of R&D at Amgen, said that SHPT needs better treatment options in patients with CKD. “There is an important role for an effective calcimimetic that can be administered intravenously with hemodialysis to help treat this disease. We are encouraged by the results of this study and look forward to sharing results from a second placebo-controlled study later this year, and a head-to-head study evaluating AMG 416 compared to cinacalcet next year."

Secondary HPT is a common, serious, and progressive condition in patients with CKD. The disorder stems from the body’s adaptive response to decline in kidney function in CKD patients when the parathyroid glands increase PTH production to try and stabilize normal calcium and phosphorus levels. Excess PTH however, does not stabilize these levels and manifests as abnormal PTH at the point when the patient’s kidney disease necessitates dialysis.

The company said it will report more data later in the year from a second Phase III trial investigating the drug against placebo.