FibroGen’s roxadustat (FG-4592) meets primary endpoints in two Phase 3 anemia studies in China.
FibroGen, Inc., a science-based biopharmaceutical company, and its subsidiary FibroGen China Medical Technology Development Co., Ltd. (FibroGen China), reported positive topline results from the two Phase 3 clinical studies of roxadustat (FG-4592) designed to support a new drug application submission in China. Roxadustat is a first-in-class, orally administered small molecule for treatment of anemia in dialysis-dependent CKD (DD-CKD) and non-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<0.00001).
- 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<0.00001).
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.
Initial findings suggest that adverse events were consistent with previous clinical trials of roxadustat in the CKD patient population with no new or unexpected safety signals identified. The 52-week safety assessment in at least 100 patients is ongoing with expected study completion in June 2017. Full results from these Phase 3 trials are expected to be reported in due course.
“We are grateful for the opportunity to advance development of treatment for anemia associated with CKD, a serious and potentially life-threating condition, for patients in China and worldwide,” said Tom Neff, chief executive officer of FibroGen. “We are very encouraged by the topline results of these two pivotal Phase 3 studies for roxadustat, which bring us closer to the first oral anemia therapy that does not require injectable administration or IV iron supplementation. In addition, use of roxadustat is free of the burden of cold-chain storage and maintaining sterility, and costly distribution infrastructure. Data from these two studies will be used to complete our new drug application submission in China later this year.”
FibroGen and AstraZeneca are collaborating for the development and commercialization of roxadustat in China, the U.S., and other markets. In China, FibroGen is conducting all clinical trials and will hold all roxadustat regulatory licenses and permits to be issued by China regulatory authorities. After market approval, FibroGen China will manage manufacturing and medical affairs and AstraZeneca will manage launch and commercialization activities in China.
(Source: Globe Newswire)
Filed Under: Drug Discovery