FG-4592: Phase IIb data

An open-label Phase IIb trial in 96 patients with stage 3/4 CKD who were not on dialysis showed that thrice-weekly oral FG-4592 led to an increase in hemoglobin of >=1 g/dL in 96% of patients. Additionally, 93% of patients achieved a hemoglobin response defined as an increase in hemoglobin of >=1 g/dL and an absolute hemoglobin concentration of >=11 g/dL for arms A and B of the trial and >=10.5 g/dL for arms C and D. The maximum mean hemoglobin increase from baseline across all treatment groups was 2.09 g/dL at week 17. FG-4592 also significantly reduced mean arterial pressure and platelet counts at the end of treatment compared to baseline (p=0.03 and p<0.01, respectively). FG-4592 was well tolerated with non-treatment related hypertension reported in 7% of patients. ...