New drug for high potassiumemia! AstraZeneta's Lokelma performed strongly in Asian patients to reduce and maintain normal blood potassium levels:

British pharmaceutical giant AstraZeneca recently presented data from HARMONIZE Global, a clinical study of the highly potassium blood drug Lokelma (sodium cyclosilate, ZS-9), at the Annual Kidney Week Meeting of the American Society of Nephrology (ASN) in San Diego. The study, conducted in patients with high potassiumemia in four Asian countries (Japan, South Korea, Taiwan, Russia), assessed the efficacy and safety of Lokelma over placebo. Data show that during the 8-29 day maintenance period, Lokelma maintained normal blood potassium levels in patients with high potassiumemia from four Asian countries.
HARMONIZE Global was a randomized, multi-center, double-blind, placebo-controlled study that included 267 cases of high potassiumemia (average blood potassium level>5.0mEq/L) in 47 study sites in the Asia-Pacific region. Patients who received The first 48 hours of 3 treatments at Lokelma dose 3 times a day (average blood potassium level: 3.5-5.0mEq/L) entered a 28-day maintenance period. During the maintenance period, patients were randomly given Lokelma 5mg, 10mg or a placebo once a day. The results showed that two doses of Lokelma showed statistically significant differences in maintaining normal blood potassium levels compared to placebos on the 8th-29th day of the maintenance period. The safety observed in this study is consistent with previous studies.
AstraZenecon's vice president of global drug development and head of cardiovascular, kidney and metabolic research, Elisabeth Björk, said the positive results of the HARMONIZE Global study added to the growing body of evidence supporting Lokelma's treatment for adult high potassiumemia, a serious disease associated with chronic kidney disease, heart failure and diabetes, and the use of nephrogen-angiosin-aldosterone system inhibitors. Through our robust clinical development programs, we are committed to assessing Lokelma's potential in the broadest possible patient population, including markets with highly unsympathetic medical needs.
, Lokelma has been approved by the United States and the European Union for the treatment of high potassiumemia in adults. AstraZeneta has plans to file regulatory applications with other markets. Data from the HARMONIZE Global study will support Lokelma's regulatory applications in Japan, South Korea, Taiwan, and Russia.
Lokelma is an insoluble, non-absorbent new selective cation exchanger designed to capture potassium ions first. As a potassium binding agent, Lokelma has developed a high potassium blood disorder commonly found in patients with chronic kidney disease or heart failure, a high potassiumemia treatment considered best-in-class, with sales expected to peak at more than $1 billion. Lokelma was developed by ZS Pharmaceuticals, which AstraZeneta acquired in November 2015 after acquiring ZS Pharmaceuticals for $2.7 billion. The acquisition is also AstraZenecom's move to strengthen its cardiovascular/metabolic disease research.
high blood potassium (serum potassium level >5.0mEq/L) usually occurs in patients with advanced kidney disease and/or chronic heart failure and can lead to cardiac arrest and death. In addition, the use of conventional heart disease drugs, such as RAAS inhibitors, can also lead to an increased risk of high blood potassium. At present, there are limited treatment options for high-blood potassium disease, and there are huge medical needs in this field that are far from being met. (Bio Valley)