Akebia Therapeutics (NASDAQ:AKBA) vadadustat met its primary endpoint in two pivotal Phase 3 clinical trials for anemia due to chronic kidney disease (CKD).
The trials compared the safety and efficacy of vadadustat to an erythropoiesis stimulating agent – which is injected and is currently the standard of care – in both dialysis-dependent and non-dialysis dependent CKD patients. Vadadustat met its primary endpoint of non-inferiority in both patient groups.
Vadadustat’s mechanism of action is designed to mimic the increase in red blood cell production that results at higher altitudes. The orally administered drug candidate inhibits the degradation of hypoxia-inducible factor (HIF), which is released in response to lower oxygen availability.
The studies were conducted by Mitsubishi Tanabe Pharma Corporation (MTPC), Akebia’s development and commercialization partner in Japan. MTPC expects to submit a Japanese New Drug Application for vadadustat in 2019.
