Phase III study of GSK 1278863 meets primary endpoint in anaemia from chronic kidney disease.- GlaxoSmithKline.

GlaxoSmithKline announced the results from a randomised, double blind, active-controlled phase III study in Japanese patients to evaluate GSK 1278863 (daprodustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, as a potential treatment for anaemia associated with chronic kidney disease (CKD).

Results from the 52-week study of 271 haemodialysis-dependent patients, showed that oral daprodustat met its primary endpoint of non-inferiority to darbepoetin alfa IV injection, as measured by mean change from baseline in hemoglobin levels over Weeks 40 to 52. The safety profile was consistent with that observed in the previous studies of daprodustat, and across all treatment arms. The percentage of patients who experienced at least one on-therapy adverse event was 93% in the daprodustat group and 97% in the control group. The most common adverse events across the treatment groups were nasopharyngitis (42% daprodustat and 54% control), gastrointestinal events (46% daprodustat and 46% control), and shunt stenosis (14% daprodustat and 15% control).

Comment: Results from this study are part of the ongoing Phase III programme being conducted in Japan to support submission to the Japanese Ministry of Health, Labour and Welfare in 2019. Positive results from the first phase III study were presented at the American Society of Nephrology�s Kidney Week in October 2018. Results from the final Japan study in non-dialysis dependent patients are anticipated in 1H2019.