Akebia Therapeutics Inc. announced several corporate and clinical developments consistent with its objectives for 2015, including dosing the first patient in its global Phase 3 PRO2TECT program in December. This program is evaluating vadadustat (formerly AKB-6548) in non-dialysis patients with anemia related to chronic kidney disease (NDD-CKD). In addition, the U.S. Food and Drug Administration (FDA) recently opened Akebia's Investigational New Drug (IND) application, allowing the company to initiate a Phase 1 clinical study of AKB-6899, an orally-available HIF stabilizer, in oncology.

The company also made progress with its intellectual property efforts in Japan for vadadustat. The PRO2TECT Phase 3 program includes two separate studies that will collectively enroll approximately 3,100 NDD-CKD patients across 500 sites globally. The first patient was recently dosed in the PRO2TECT correction study, which is enrolling anemic 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 hemoglobin levels. Both studies include a 1:1 randomization and an open label, active-control, non-inferiority design. Primary endpoints include an efficacy assessment of the hemoglobin response and cardiovascular safety as measured by major adverse cardiovascular events.

The PRO2TECT program 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 (CKD) patients. The company expects to complete enrollment in late 2017.