HARMONIZE Global Phase III trial results for Lokelma presented at ASN Kidney Week.- AstraZeneca.

AstraZeneca presented the results from the HARMONIZE Global Phase III trial, which investigated the safety and efficacy of Lokelma (sodium zirconium cyclosilicate) vs. placebo in patients with hyperkalaemia in Japan, Korea, Taiwan and Russia. The results were presented at the American Society of Nephrology (ASN) Kidney Week 2018, San Diego, California, US.

Hyperkalaemia is a serious condition characterised by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases. HARMONIZE Global is a randomised, multicentre, double-blinded, placebo-controlled trial involving 267 patients with hyperkalaemia (mean potassium levels greater than 5.0 mEq/L) in 47 study locations across the Asia Pacific region. Patients who achieved normokalaemia (mean potassium levels of 3.5-5.0 mEq/L) during the first 48 hours with Lokelma 10g three times daily (93%; n=248) progressed to the 28-day maintenance phase of the trial. Patients in the maintenance phase were randomised to receive Lokelma 5g or 10g, or placebo, administered once daily. Results show normokalaemia was maintained with statistically-significant differences observed, irrespective of dose, for Lokelma vs. placebo in terms of mean potassium levels during days 8-29 of the maintenance phase. The safety profile of Lokelma observed in HARMONIZE Global was consistent with previous trials.

Comment:Lokelma is a key potential product for one of AstraZeneca�s future strategic therapeutic areas, the treatment of chronic kidney disease. The sector also includes roxadustat, a Phase III hypoxia-inducible factor prolyl hydroxylase inhibitor being evaluated in collaboration with FibroGen Inc. Roxadustat may reverse the anemia seen in chronic kidney disease, and a US approval filing is expected in 2018.