Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) indicated to promote erythropoiesis by increasing endogenous production of erythropoietin
Image: AstraZeneca unveils Phase III clinical studies of Roxadustat. Photo: Courtesy of AstraZeneca.
AstraZeneca has unveiled results from the Phase III OLYMPUS and ROCKIES trials, which showed that roxadustat increased haemoglobin (Hb) levels in non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients with anaemia from chronic kidney disease (CKD), respectively.
Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) designed to promote erythropoiesis by increasing endogenous production of erythropoietin.
AstraZeneca BioPharmaceuticals R&D executive vice president Mene Pangalos said: “Anaemia is a common, serious condition among patients with chronic kidney disease. It occurs when the body has fewer healthy red blood cells than normal and low levels of haemoglobin, which may leave patients fatigued and short of breath.
“Results from OLYMPUS and ROCKIES reinforce the potential role that roxadustat could play in increasing haemoglobin levels and managing anaemia, which is often underdiagnosed and undertreated.”
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The company said that the roxadustat helps in coordinating erythropoiesis and increasing red blood cell count in multiple subpopulations of CKD patients, with inflammation and avoids need for supplemental IV iron.
OLYMPUS is a Phase III, randomised, double blind, placebo-controlled clinical study designed to assess the efficacy and safety of roxadustat compared to placebo in treating the NDD patients with anaemia from CKD stages.
ROCKIES is a Phase III, randomised, open-label, active-controlled trial aimed at evaluating the efficacy and safety of roxadustat compared to epoetin alfa, in treating patients with anaemia in DD-CKD.
OLYMPUS and ROCKIES, both are AstraZeneca-sponsored trials, and are part of the global Phase III clinical trials programme. The results showed that both OLYMPUS and ROCKIES have reached their respective primary efficacy endpoints.
Among the patients treated with roxadustat, diarrhoea, hypertension, pneumonia, headache and arteriovenous fistula thrombosis were the most frequently reported adverse events, in addition to the sepsis and acute myocardial infarction, which are serious adverse events.
AstraZeneca said that it intends to use the data from the Phase III OLYMPUS and ROCKIES trials, together with the efficacy and pooled CV safety data from the global Phase III programme for the regulatory submission in the US, which is expected in the fourth quarter 2019.
OLYMPUS and ROCKIES trials primary investigator Steven Fishbane said: “These data demonstrated that roxadustat effectively increased haemoglobin levels for patients with anaemia from chronic kidney disease, including those who show signs of inflammation.
“Patients who experience chronic inflammation are often more difficult to treat than the overall chronic kidney disease patient population, emphasising the need for new treatment options.”