Biotech Values

[DewDiligence]

AKBA—(-68%/PM)—fails MACE (safety) endpoint in phase-3 NDD trial:

https://www.prnewswire.com/news-releases/akebia-therapeutics-announces-top-line-results-from-its-pro2tect-global-phase-3-program-of-vadadustat-for-treatment-of-anemia-due-to-chronic-kidney-disease-in-adult-patients-not-on-dialysis-301123808.html

Akebia Therapeutics…today announces top-line results from PRO2TECT, the second of its two global Phase 3 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.

Vadadustat achieved the primary and key secondary efficacy endpoint in each of the two PRO2TECT studies, demonstrating non-inferiority (NI) 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). Vadadustat did not meet the primary safety endpoint of the PRO2TECT program, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of major adverse cardiovascular events (MACE), which is the composite of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke across both PRO2TECT studies.