Pivotal data on Akebia's anaemia project please, but safety concerns linger

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Good news from Akebia: the first phase III trials of its experimental anaemia treatment, vadadustat, succeeded, prompting a 17% jump in its shares in early trade. Four Japanese trials run by the group's partner Mitsubishi Tanabe were top-lined, two of which were pivotal; these found vadadustat to be non-inferior to darbepoetin alfa in patients with chronic kidney disease. Vadadustat is a contender in the new HIF-PH inhibitor class, which developers hope will prove safer and more effective than EPO drugs like darbepoetin. Fibrogen is leading this field and has set a very high bar with roxadustat, which already has impressive pivotal data in the bank. In trials similar to those announced by Akebia today, roxadustat was found to be superior to Epogen, though differences in trial design make drawing firm conclusions about comparative efficacy almost impossible. On safety, Akebia reported one fatal myocardial ischaemia, which was considered possibly related to vadadustat, though investors seem to have shrugged this off. This is surprising considering that cardiac safety remains a big question mark for the HIF-PH inhibitors; a hugely important pooled analysis of the roxadustat data, searching for cardiac signals, is due in the coming the weeks, and should provide a definitive answer. 

A first look at vadadustat in phase III: results from Japan
  J01 Study (non-dialysis dependent CKD, NCT03329196) J03 Study (dialysis dependent CKD, NCT03439137)
  vadadustat darbepoetin alfa vadadustat darbepoetin alfa
Mean haemoglobin (Hb) at wk 20 and wk 24 11.66g/dL 11.93g/dL 10.61g/dL 10.65g/dL
Difference in mean Hb -0.26 g/dL   -0.05 g/dL  
Non-inferiority criterion -0.75 g/dL   -0.75 g/dL  
Source: Company press release.        

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