RLY5016: Phase II data

An open-label, single-arm Phase II trial in 63 heart failure patients with CKD who were already receiving standard renin-angiotensin-aldosterone system (RAAS) blocker therapy showed that 90% (n=57) of patients treated with oral RLY5016 plus spironolactone achieved serum potassium levels in the normal range of 3.5-5.5 mEq/L, the primary endpoint, at week 8. Relypsa said there was no pre-specified threshold for meeting the endpoint. In a subset of 12 patients with both diabetes and albuminuria, RLY5016 reduced mean blood pressure from 140/84 mmHg at baseline to 132/78 mmHg at week 8 (p=0.119 and p=0.019 for systolic and diastolic blood pressure, respectively), and significantly reduced mean UACR from 1,526 mg/g at baseline to 707 mg/g at week 8 (p<0.001). RLY5016 was well tolerated with mild to moderate gastrointestinal side effects reported in 16% of patients. Data were presented at the American Society of Hypertension meeting in New York. ...