Policy & Regulation
Akebia Therapeutics Reports Full Enrollment of Phase 3 INNO2VATE Studies
15 May 2019 - - US-based biopharmaceutical company Akebia Therapeutics, Inc. (NASDAQ: AKBA) has completed
full enrollment of its global Phase 3 INNO2VATE studies for vadadustat, the company said.

Enrollment in the global Phase 3 INNO2VATE studies evaluating the safety and efficacy of vadadustat in dialysis-dependent CKD subjects with anemia due to CKD, has been completed. Enrollment in the smaller of the two INNO2VATE studies, was completed in April 2019, with a total of 369 subjects enrolled.

Enrollment in the larger INNO2VATE study was completed in February 2019, with a total of 3,554 subjects enrolled.

The company continues to expect to report top-line data from both INNO2VATE studies in 2Q20, subject to the accrual of major adverse cardiovascular events.

The company expects enrollment in the global Phase 3 PRO2TECT studies evaluating the safety and efficacy of vadadustat in non-dialysis dependent CKD subjects with anemia due to CKD, to be completed in 2019, with up to approximately 3,700 subjects expected to be enrolled.

The company continues to expect to report top-line results in mid-2020, subject to the accrual of MACE.

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor currently in global Phase 3 development for the treatment of anemia due to CKD.

Vadadustat's proposed mechanism of action is designed to mimic the physiologic effect of altitude on oxygen availability.

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

Vadadustat is an investigational therapy and is not approved by the US Food and Drug Administration (FDA) or any regulatory authority.
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