Kremezin: Phase III data

Top-line data from the double-blind, international Phase III EPPIC-1 and EPPIC-2 trials in about 2,000 patients total with moderate to severe CKD showed that once-daily 9 g AST-120 plus standard of care (SOC) missed the composite primary endpoint of time to initiation of dialysis, kidney transplantation or doubling of serum creatinine levels vs. placebo. Mitsubishi and Kureha said that data from a subgroup analysis suggested that AST-120 "was effective in patients with factors associated with fast progressive CKD." The companies could not be reached for details. Additional data will be presented at the American Society of Nephrology meeting in San Diego in November. ...