Akebia: Data in Phase 2 study consistent with findings from previous studies
Akebia Therapeutics announced top-line results from its Phase 2 study of vadadustat in patients with anemia associated with dialysis-dependent chronic kidney disease in Japan. The results are consistent with findings from previous studies of vadadustat. Akebia's partner, Mitsubishi Tanabe Pharma Corporation, is conducting a Phase 3 study of non-dialysis dependent patients in Japan and, based upon the data announced today, is expected to begin Phase 3 studies in DD-CKD patients in Japan in 2018. Under the terms of the collaboration agreement with MTPC, Akebia will receive $10M in milestone payments in conjunction with the start of the Phase 3 studies. The double-blind, placebo-controlled, dose-finding Phase 2 study was designed to evaluate the efficacy, safety and tolerability of orally-administered vadadustat in Japanese patients with anemia associated with DD-CKD. This 16-week study evaluated 60 patients during a 6-week placebo-controlled, fixed-dose period and a 10-week active treatment, dose adjustment and maintenance period. The primary efficacy endpoint was mean hemoglobin change from baseline to week 6 comparing vadadustat to placebo. Statistically significant improvements in the primary endpoint were observed in the vadadustat groups, 150 mg, 300 mg and 600 mg, compared to placebo. The data indicate a dose-response for vadadustat.