AstraZeneca has announced that the phase 3 OLYMPUS and ROCKIES trials for roxadustat each met respective primary efficacy endpoints for the treatment of patients with anemia in chronic kidney disease that are either non-dialysis-dependent or dialysis-dependent, according to a company press release.
AstraZeneca and FibroGen Inc. are jointly developing the hypoxia-inducible factor prolyl hydroxylase inhibitor to act as a potential first-in-class treatment for anemia in CKD.
The global phase 3 program consists of more than 9,000 patients in trials conducted by AstraZeneca, FibroGen and Astellas. These trials will contribute to the combined pooled safety analysis, including major adverse cardiovascular event outcomes, in the first half of 2019.
The OLYMPUS trial met its primary efficacy endpoint by demonstrating a statistically significant and clinically meaningful improvement in mean change from baseline in hemoglobin levels averaged over weeks 28 to 52 vs. placebo, according to the release. The trial evaluated 2,781 patients in 26 countries.
The ROCKIES trial met its primary efficacy endpoint by demonstrating a statistically significant improvement in mean change from baseline in hemoglobin levels averaged over weeks 28 to 52 vs. epoetin alfa. The trial evaluated 2,133 patients in 18 countries.
“These results add to the growing body of evidence for roxadustat, which is part of the largest clinical program worldwide in evaluating the novel class of HIF-PHI,” Sean Bohen, executive vice-president of global medicines development and chief medical officer at AstraZeneca, said in the release. “This is a significant milestone in the role roxadustat can play to help address a high unmet need in anemia associated with chronic kidney disease, which today is under diagnosed and in many cases under treated.”