SAN FRANCISCO, Oct. 31, 2016 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN), a research-based biopharmaceutical company, today reported completion of enrollment in its Phase 3 clinical trials in China for roxadustat (FG-4592) in chronic kidney disease (CKD) patients suffering from anemia. The program includes trials in both CKD patients on dialysis and CKD patients not on dialysis.
“The completion of enrollment in both the roxadustat non-dialysis and dialysis Phase 3 clinical trials in China is an important milestone for our company, as our first FibroGen Phase 3 clinical development program ─ and the first roxadustat Phase 3 program ─ to be fully enrolled,” said Thomas B. Neff, Chief Executive Officer of FibroGen, Inc. “We believe roxadustat has the potential to transform anemia treatment in China, where our development timeline remains on track. We are initiating the new drug application submission process in 2016, with topline data from these trials expected by early 2017.”
The roxadustat China Phase 3 studies are designed to support approval of roxadustat for treatment of anemia in CKD patients who are dialysis-dependent and CKD patients who are not dialysis-dependent. The dialysis study (FGCL-4592-806) is a multi-center, open-label, active control study in which 300 stable dialysis-dependent CKD patients previously treated with erythropoiesis-stimulating agents are randomized 2:1 to receive roxadustat or epoetin alfa, with a primary efficacy endpoint of mean change in hemoglobin from baseline. The non-dialysis study (FGCL-4592-808) is a multi-center, double-blind, placebo-controlled study in which 150 non-dialysis-dependent CKD patients are randomized 2:1 to receive roxadustat or placebo with a primary efficacy endpoint of mean change in hemoglobin from baseline. The primary efficacy endpoint of the dialysis study is at 26 weeks and the primary efficacy endpoint for the non-dialysis placebo-controlled portion is at 8 weeks, with initial treatment continuing until 26 weeks. The safety assessment will continue until at least 100 subjects have received a minimum of 52 weeks of exposure to roxadustat, which is expected to occur in the second quarter of 2017.
About Roxadustat (FG-4592)
Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor prolyl hydroxylase activity (a HIF-PHI) , currently in global Phase 3 clinical development as a potential therapy for anemia associated with CKD in patients on dialysis and not on dialysis. Hypoxia-inducible factor (HIF) is a transcription factor that induces the natural physiological response to conditions of low oxygen, “turning on” erythropoiesis (the process by which red blood cells are produced) and other protective pathways. Intermittent administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range, which increases iron bioavailability and counters the EPO-suppressive effects of inflammation.
AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat (FG-4592) for the treatment of anemia in patients with CKD in the U.S., China, and other markets. Astellas and FibroGen are collaborating on the development and commercialization of roxadustat in Europe, Japan, the Commonwealth of Independent States, the Middle East, and Africa. The global clinical development program for roxadustat features four regulatory pathways – U.S., Europe, China, and Japan – and has advanced in each of these jurisdictions to Phase 3, supported by extensive Phase 2 data showing roxadustat correction and maintenance of hemoglobin levels in multiple subpopulations of CKD patients.
For information about roxadustat studies that are currently recruiting patients, please visit clinicaltrials.gov at this link: https://clinicaltrials.gov/ct2/results?term=roxadustat&Search=Search.
About Chronic Kidney Disease and Anemia in China
Chronic kidney disease (CKD) affects an estimated 119.5 million patients in China. (Zhang et al. Lancet 2012; 379: 815–822.) Although CKD may occur at any age, it is more common in aging populations and its prevalence is increasing. CKD can be both a cause and a consequence of cardiovascular disease and is now a critical worldwide healthcare issue that represents a large and growing unmet medical need. Currently, no curative treatment or ability to stop kidney deterioration in patients with CKD exists with the exception of kidney transplantation.
Anemia commonly develops in association with CKD and is associated with significant morbidity and mortality in both the dialysis and non-dialysis populations. The number of patients that require anemia therapy is expected to grow steadily as the global CKD population continues to expand, particularly in China and other emerging markets. In China, anemia remains undertreated in a rapidly growing dialysis population, similar in size to the U.S dialysis population, with a shortage of dialysis facilities relative to the number of dialysis-eligible patients. Non-dialysis patients in China are also largely untreated, including the vast majority of one to two million dialysis-eligible patients who do not receive dialysis. We believe there is a significant opportunity for roxadustat to address anemia in patient segments that are currently not effectively served by erythropoiesis-stimulating agents, such as the CKD non-dialysis population, which is substantially larger than the CKD dialysis-dependent patient population. In the context of the rapidly growing Chinese pharmaceutical market, we believe that the demand for anemia therapy will continue to grow as a result of an expanding CKD population.
About FibroGen
FibroGen is a research-based biopharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics to treat serious unmet medical needs. The company utilizes its extensive experience in fibrosis and hypoxia-inducible factor (HIF) biology to generate development programs in multiple therapeutic areas. Its most advanced product candidate, roxadustat (FG-4592), is an oral small molecule inhibitor of HIF prolyl hydroxylase activity in Phase 3 clinical development for the treatment of anemia in CKD. A second product candidate, pamrevlumab (FG-3019), our fully-human monoclonal antibody that inhibits the activity of CTGF, is in Phase 2 clinical development for the treatment of IPF, pancreatic cancer, and DMD. For more information please visit: www.fibrogen.com.
Forward-Looking Statements
This release contains forward-looking statements, including statements regarding the potential ability of roxadustat to treat anemia in CKD patients, and the potential commercial market for roxadustat, timeline for reporting data, and clinical and regulatory developments for roxadustat. Our actual results may differ materially from these early data and any forward-looking statements due to risks and uncertainties that are described in our Annual Report on Form 10-K and our quarterly reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.