Positive Ph III results for Relypsa's patiromer FOS for hyperkalemia

US biotech firm Relypsa (Nasdaq: RLYP) announced that positive results from the pivotal Phase III program of the company's lead product candidate, patiromer for oral suspension (FOS), were published on Friday in New England Journal of Medicine.

The program was conducted under Special Protocol Assessment to evaluate the safety and efficacy of patiromer (a high capacity oral potassium binder) FOS for the treatment of hyperkalemia (HK) in chronic kidney disease (CKD) patients on renin-angiotensin-aldosterone system (RAAS) inhibitor therapy. Hyperkalemia is a serious condition defined as abnormally elevated potassium levels in the blood.

Lead author, Matthew Weir, Professor and Director, Division of Nephrology, University of Maryland School of Medicine, commented "Hyperkalemia remains our primary concern in patients on kidney- and cardio-protective RAAS therapy. We are pleased to have these exciting results for patiromer FOS published in New England Journal of Medicine. The rigor of the Phase III program gives me confidence in the clinical evidence which I believe sufficiently supports the company's application to gain approval of patiromer FOS as a treatment for hyperkalemia."