Shares of US biotech Akebia Therapeutics (Nasdaq: AKBA) were up more than 35% at $11.72 by early afternoon today, after it announced positive top-line results from INNO2VATE, the first of its two global Phase III cardiovascular outcomes programs.
The two INNO2VATE 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 on dialysis.
Vadadustat achieved the primary and key secondary efficacy endpoint in each of the two INNO2VATE studies, demonstrating non-inferiority to darbepoetin alfa as measured by a mean change in hemoglobin (Hb) between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52).
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