AstraZeneca Stops Two Lokelma Late-Stage Trials After Evaluating Potential Benefits

AstraZeneca Plc AZN discontinued the STABILIZE-CKD and DIALIZE-Outcomes Phase 3 evidence trials for Lokelma (sodium zirconium cyclosilicate). 

The decision was made due to substantially increased enrollment timelines and low event rates, respectively, which made it prohibitive to deliver study results within a timeframe to advance clinical practice meaningfully.

Also Read: FDA Approves AstraZeneca's Truqap/Faslodex Combo Therapy For Breast Cancer, Competes With Gilead's Drug.

STABILIZE-CKD and DIALIZE-Outcomes trials are part of the CRYSTALIZE evidence program, which includes clinical and real-world evidence studies researching the potential benefit of Lokelma in the management of hyperkalemia (HK) across the cardiorenal spectrum.

Hyperkalemia is the medical term that describes a potassium level in blood that's higher than normal. Potassium is a chemical critical to the function of nerve and muscle cells, including in the heart.

The company will work with investigators to ensure the necessary follow-up with patients.

Lokelma is approved for a broad HK patient population in 56 countries worldwide. The decision to discontinue the trials is not due to safety concerns, and the positive benefit-risk of Lokelma does not change in the approved indication.

Price Action: AZN shares closed at $64.59 on Thursday.