FG-4592: Interim Phase II data

Interim data from the first cohort of 52 patients in an ongoing, open-label, U.S. Phase II trial showed that 1.5 and 2 mg/kg oral FG-4592 thrice weekly was superior to IV Epogen epoetin alfa at week 6 in mean hemoglobin increase from baseline (1 vs. 0.8 g/dL, p<0.001 for each) and in the percentage of patients who maintained baseline hemoglobin levels (89% vs. 40%, p=0.011 for pooled dosages). The 1 mg/kg dose was not superior to Epogen on either endpoint, which the company said were exploratory.

Compared with Epogen, the two highest doses significantly reduced hepcidin levels (p=0.04), while all 3 doses significantly increased mean corpuscular volume (p=0.04) and serum iron (p=0.02). There were no FG-4592-related safety signals. Data were presented at the National Kidney Foundation meeting in Las Vegas. ...