FibroGen and FibroGen China Medical Technology Development Reports Positive Top Line Results from the Two Phase 3 Clinical Studies of Roxadustat
January 30, 2017 at 12:00 pm
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FibroGen, Inc. and its subsidiary FibroGen China Medical Technology Development Co., Ltd. reported positive top line results from the two Phase 3 clinical studies of roxadustat. Roxadustat is a first-in-class, orallya dministered small molecule for treatment of anemia in dialysis-dependent CKD (DD-CKD) andnon-dialysis-dependent CKD (NDD-CKD) patients. Both of the Phase 3 studies met their primary efficacy endpoints, which were evaluated in the comparator-controlled portions of the studies. In the double-blind, placebo-controlled eight-week portion of the 26-week NDD-CKD trial, 151 anemia patients were randomized 2:1 to receive roxadustat (n=101) or placebo (n=50). Roxadustat met its primary efficacy endpoint of correcting anemia, by achieving a statistically significant increase in hemoglobin (Hb) levels compared to placebo over eight weeks. Furthermore, the secondary endpoint of Hb response was met as Hb response was achieved by a higher proportion of patients in the roxadustat arm than in the placebo arm. Roxadustat-treated patients achieved a mean Hb increase of 1.9g/dL from baseline (8.9g/dL) over eight weeks of treatment vs. a mean change in Hb of -0.4g/dL (from 8.9 g/dL baseline) in the placebo arm (p). A significantly higher proportion of roxadustat patients achieved Hb response (an increase =1g/dL from baseline) after eight weeks vs. placebo patients, 84.2% compared to 0.0% (p). In the dialysis study, 304 patients (271 hemodialysis and 33 peritoneal dialysis patients) previously on epoetin alfa were randomized to and treated with roxadustat (n=204) or epoetin alfa (n=100) for 26 weeks. All the patients randomized to the active comparator arm were treated with (“Li Xue Bao”) epoetin alfa, manufactured in Japan and marketed in China by Kyowa Hakko Kirin China Pharmaceutical Co. Ltd. (Kirin EPO). The primary endpoint was Hb change from baseline to the Hb level averaged during the final five weeks of the 26-week treatment period. Roxadustat met the predefined non-inferiority criterion for its primary endpoint in comparison to Kirin EPO in both full analysis set (FAS) and per protocol set (PPS) analyses. Furthermore, on superiority testing of the primary endpoint, the mean Hb increase observed in the roxadustat arm was higher than in the Kirin EPO arm, 0.75g/dL vs. 0.46g/dL (p=0.037) in PPS analysis.
FibroGen, Inc. is a biopharmaceutical company. The Company is engaged in developing and commercializing a diversified pipeline of novel therapeutics that work at the frontiers of cancer biology and anemia. Its clinical, commercial, and research programs include Pamrevlumab, which is a first-in-class antibody being developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF). Pamrevlumab is in Phase III clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC) and in Phase 2/3 for the treatment of metastatic pancreatic cancer and Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. It also develops FG-3165: Anti-Gal9 Antibody and FG-3175: Anti-CCR8 Antibody.
FIBROGEN, INC. 
