Akebia starts phase 3 program to evaluate vadadustat for second indication in renal anemia

Known as INNO2VATE, the program consists of two studies designed to evaluate vadadustat in patients with anemia related to chronic kidney disease who are undergoing dialysis. Akebia's ongoing Phase 3 PRO2TECT program in non-dialysis dependent patients with anemia related to chronic kidney disease commenced at the end of last year.

"The launch of the INNO2VATE program represents an important milestone for our global vadadustat Phase 3 program," stated John P. Butler, President and Chief Executive Officer of Akebia.

"Similar to our parallel Phase 3 PRO2TECT program in patients who are not currently on dialysis, INNO2VATE is designed to demonstrate the best-in-class potential of vadadustat to treat patients who are suffering from anemia related to chronic kidney disease."

The INNO2VATE program includes two separate studies and will collectively enroll approximately 2,600 dialysis-dependent patients with anemia related to chronic kidney disease.

Both studies will 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 an assessment of cardiovascular safety as measured by standard major adverse cardiovascular events (MACE) criteria.

The INNO2VATE-Correction study will evaluate patients not currently being treated with recombinant erythropoiesis stimulating agents (rESAs). The INNO2VATE-Conversion study will evaluate patients currently receiving rESA who will be converted to either vadadustat or the active control, with the goal of maintaining their baseline hemoglobin levels.

About Vadadustat

Vadadustat is an oral hypoxia-inducible factor (HIF) stabilizer with best-in-class potential for the treatment of anemia related to chronic kidney disease. Vadadustat, currently in development, exploits the same mechanism of action used by the body to naturally adapt to lower oxygen availability associated with a moderate increase in altitude.

At higher altitudes, the body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilization and erythropoietin production to increase red blood cell production and, ultimately, improve oxygen delivery.

About Anemia Related to Chronic Kidney Disease

Approximately 30 million people in the U.S. have chronic kidney disease (CKD), with an estimated 1.8 million of these patients suffering from anemia. Anemia results from the body's inability to coordinate red blood cell production in response to lower oxygen levels due to the progressive loss of kidney function, which occurs in patients with CKD.

Left untreated, anemia significantly accelerates patients' overall deterioration of health with increased morbidity and mortality. Renal anemia is currently treated with injectable recombinant erythropoiesis stimulating agents, which are associated with inconsistent hemoglobin responses and well-documented safety risks.