Akebia Therapeutics initiates Phase III PRO2TEC programme for vadadustat to treat anaemia related to chronic kidney disease

Akebia Therapeutics announced dosing the first patient in its global Phase III PRO2TECT programme in December.

This programme is evaluating vadadustat (formerly AKB-6548) in non-dialysis patients with anaemia related to chronic kidney disease (NDD-CKD). The PRO2TECT Phase III programme includes two separate studies that will collectively enrol approximately 3100 NDD-CKD patients across 500 sites globally. The first patient was recently dosed in the PRO2TECT correction study, which is enrolling anaemic patients not currently being treated with recombinant erythropoiesis stimulating agents (rESAs). The PRO2TECT conversion study includes patients currently receiving rESA who will be converted to either vadadustat or the active control with the goal of maintaining their baseline haemoglobin levels. Primary endpoints include an efficacy assessment of the haemoglobin response and cardiovascular safety as measured by major adverse cardiovascular events. The PRO2TECT programme is designed to support registration in major markets worldwide and to collect the data required to establish a new standard of care for chronic kidney disease patients. The company expects to complete enrolment in late 2017.

Comment: Vadadustat is an orally available, hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, designed to stabilise HIF2 alpha – a critical regulator of red blood cell production and iron absorption. By working in this manner, vadadustat achieves a controlled stimulation of red blood cell production that is similar to the effect of modest increases in altitude.