Akebia Therapeutics Inc. (NASDAQ:AKBA) has announced the presentation go its INNO2VATE Phase 3 clinical study data at the 2020 Reimagined American Society of Nephrology Kidney Week.
Promising INNO2VATE Phase 3 results
The presented results showed that vadadustat demonstrated cardiovascular safety and efficacy in treating anemia, resulting because of chronic kidney diseases in patients on dialysis. Vadadustat is the company’s experimental oral hypoxia-inducible factor prolyl hydroxylase inhibitor currently in development for treating anemia resulting from chronic kidney disease.
Professor Kai-Uwe Eckardt, t5he co-chair of the Executive Steering Committee for the INNO2VATE study, said that the presented data builds on the previous efficacy and safety data reported in May. Most importantly, the cardiovascular safety profile of vadadustat in CKD patients undergoing dialysis reinforces the newly presented data. The data shows that vadadustat attained non-inferiority to darbepoetin alfa on expanded MACE, MACE, cardiovascular mortality, cardiovascular MACE, and all-cause mortality.
Eckardt said that the results were consistent across several populations. If anemia in CKD patients on dialysis is left untreated, it can result in high transfusion needs and significantly reduce patients’ quality of life. The INNO2VATE results have shown that vadadustat can be a good oral treatment alternative for dialysis patients after it receives approval.
Results sets stage for vadadustat approval
The company presented the results during the ASN Kidney week under presentation title, “Global Phase 3 Clinical Trials of Vadadustat vs Darbepoetin Alfa for Treatment of Anemia in Patients with Dialysis-Dependent Chronic Kidney Disease.”
Akebia CEO and President John Butler said that they are delighted and satisfied with the compelling results across the clinical development .program in CKD patients on dialysis for vadadustat. He said that the data was clear and consistent, which set the stage for possible vadadustat approval. It also underscores its potential as a new oral front-line care for CKD patients on dialysis experiencing anemia. This includes both prevalent and incident dialysis patients following its approval. Butler stated that they are looking forward to delivering this innovative therapy to CKD patients on dialysis globally.