INNO2VATE phase III program of AKB 6548 meets primary and secondary endpoints in anaemia due to chronic kidney disease.- Akebia Therapeutics

Akebia Therapeutics announced positive top-line results from INNO2VATE, its global Phase III cardiovascular outcomes program evaluating the efficacy and safety of AKB 6548 (vadadustat), its investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), versus darbepoetin alfa for the treatment of anaemia due to chronic kidney disease (CKD) in adult patients on dialysis.

Vadadustat achieved the primary and key secondary efficacy endpoint in each of the two INNO2VATE studies, demonstrating non-inferiority to darbepoetin alfa as measured by a mean change in hemoglobin (Hb) between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52). Vadadustat also achieved the primary safety endpoint of the INNO2VATE program, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of major adverse cardiovascular events (MACE), which is the composite of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke across both INNO2VATE studies.

Each analysis was measured against non-inferiority (NI) margins agreed upon with the FDA and the European Medicines Agency (EMA). The company is already at work on vadadustat’s New Drug Application, which it expects to file following the top-line data readout of PRO2TECT, the global Phase III program studying vadadustat in adult patients not on dialysis with anemia due to CKD, expected in mid-2020.