Akebia shares plummet as vadadustat flunks on safety in non-dialysis market

3 September 2020

US biopharma Akebia Therapeutics (Nasdaq: AKBA) opened more than 70% lower on Wednesday after the company presented top-line results from PRO2TECT, the second of its two global Phase III cardiovascular outcomes programs.

The two PRO2TECT studies evaluated the efficacy and safety of vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), versus darbepoetin alfa for the treatment of anemia due to chronic kidney disease (CKD) in adult patients not on dialysis.

"We still believe we have a path toward approval for vadadustat in non-dialysis"The company's vadadustat development program also includes two other global Phase III studies (INNO2VATE) for the treatment of anemia due to CKD in adult patients on dialysis, for which Akebia reported positive top-line data in May.

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