AstraZeneca has decided to discontinue the two late-stage trials for a drug designed to lower potassium levels for those suffering from a chronic disease known as hyperkaelemia
The company cited “substantially increased enrollment timelines and low event rates, respectively, which made it prohibitive to deliver study results within a timeframe to meaningfully advance clinical practice.”
The trials are part of the CRYSTALIZE evidence program studies researching the potential benefit of Lokelma in the management of hyperkalaemia, a condition arising from kidney diseases or drugs used to treat blood pressure and other conditions.
Sharon Barr, executive vice president, BioPharmaceuticals R&D said: “Our ambitious CRYSTALIZE program continues to generate evidence to improve the current management of hyperkalaemia, which we believe leads to better outcomes for cardiorenal patients when a potassium binder is included in their treatment regimen. Lokelma is the leading branded potassium binder globally and continues to benefit a broad hyperkalaemia patient population to achieve rapid, sustained potassium control and is well tolerated.”
Lokelma is approved for the treatment of 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, a release stated.
AstraZeneca has packaging, administrative and logistics operations in northern Delaware.