Akebia Therapeutics has reported that two pivotal Phase III clinical trials of its vadadustat drug met their primary endpoints in Japanese patients with anaemia caused due to chronic kidney disease (CKD).
The trials, J01 Study and J03 Study, were conducted in non-dialysis dependent and haemodialysis-dependent patients, respectively.
According to the top-line results, vadadustat achieved non-inferiority in the mean haemoglobin (Hb) level at week 20 and week 24, compared to patients treated with darbepoetin alfa, in both trials.
Vadadustat is an investigational, oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (HIF-PHI) designed to mimic altitude’s physiologic effect on oxygen availability.
The Phase III trials were conducted by Akebia’s development and commercialisation collaboration partner in Japan, Mitsubishi Tanabe Pharma.
J01 Study enrolled 304 Japanese non-dialysis dependent subjects with anaemia due to CKD, while J03 Study involved 323 Japanese haemodialysis patients who had prior erythropoiesis stimulating agent (ESA) therapy.
Both trials compared the efficacy and safety of vadadustat to darbepoetin alfa, an ESA.
In the J01 Study, the incidence of serious adverse events (SAEs) was 13.9% in vadadustat-treated patients compared to 14.4% in the darbepoetin alfa-treated arm. The figure was 13% versus 10.6% in the J03 Study.
Mitsubishi Tanabe Pharma also conducted two Phase III single-arm studies in peritoneal dialysis and haemodialysis subjects. Data from these studies is said to further support vadadustat’s potential in these indications.
Akebia Therapeutics president and CEO John Butler said: “Collectively, these data provide further confirmation of vadadustat’s potential to meaningfully transform the treatment paradigm for patients with anaemia due to CKD.
“These results add to our dataset demonstrating the potential for vadadustat to effectively manage haemoglobin levels in both dialysis-dependent and non-dialysis dependent patients, including those who convert from erythropoiesis stimulating agents.”
Mitsubishi Tanabe Pharma expects to submit a new drug application in Japan this year, seeking approval for the drug in these indications.
If approved, vadadustat can be prescribed as a once-daily oral treatment alternative to injectable ESAs.