AstraZeneca Discontinues Two Phase III Trials of Lokelma Due to Extended Enrollment and Low Event Rates

Dec 04, 2023 12:20 CST Updated 12:20

AstraZeneca

Biopharmaceutical Manufacturer

AstraZeneca recently announced that it will halt two late-stage trials investigating the potential benefits of its drug Lokelma in treating cardiorenal hyperkalemia. This decision was based on a significant increase in recruitment time and a lower rate of event occurrence.

Hyperkalemia (HK) is a chronic condition characterized by high levels of potassium in the blood, and Lokelma is a therapy for HK that can rapidly reduce potassium levels and provide sustained control. This treatment has been approved in 56 countries worldwide for treating a broader population of HK patients.

AstraZeneca Cancels Two Trials, STABILIZE-CKD and DIALIZE-Outcomes, Due to Significantly Increased Patient Enrollment Time and Low Event Rates, Making It Difficult to Verify Lokelma's Efficacy Within an Appropriate Time Frame.

In a statement, AstraZeneca said: "The decision to halt the trial was not due to safety concerns, and the positive benefit-risk profile of Lokelma in its approved indications remains unchanged."

Lokelma is an oral suspension powder with the active ingredient sodium zirconium cyclosilicate, an insoluble and non-absorbable zirconium silicate specifically used for treating hyperkalemia. The product received its first marketing approval in the EU in March 2018 for the treatment of hyperkalemia in adults, including end-stage renal disease patients undergoing chronic hemodialysis.

STABILIZE-CKD Study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial, originally planned to enroll 1,360 patients to evaluate the effect of Lokelma as an adjunct to optimized RAASi on CKD progression in patients with CKD and HK or at risk of HK.

DIALIZE-Outcomes is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial planning to enroll 2,800 patients, aiming to evaluate the impact of Lokelma on arrhythmia-related cardiovascular outcomes in chronic hemodialysis patients with recurrent hyperkalemia (HK).

Globally, there are approximately 840 million patients with chronic kidney disease (CKD) and 64 million patients with heart failure (HF). These patients face a risk of hyperkalemia that is 2-3 times higher than the general population. Hyperkalemia is a chronic condition characterized by elevated potassium levels in the blood (typically defined as >5 mmol/L), and patients with hyperkalemia have a higher risk of arrhythmias, which may lead to cardiac arrest.

Renin-Angiotensin-Aldosterone System Inhibitors (RAASi) are recommended by guidelines to slow the progression of CKD and reduce cardiovascular events. However, once patients are diagnosed with hyperkalemia, they often need to reduce the dosage or discontinue treatment, which may negatively impact patient outcomes. Therefore, CKD and HF patients who develop hyperkalemia require new treatment options. The termination of Lokelma’s clinical studies could affect the therapeutic prospects for this patient population.

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