FibroGen Announces Analyses from Roxadustat Global Phase 3 Program at American Society of Nephrology Kidney Week 2021
SAN FRANCISCO, Oct. 25, 2021 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ: FGEN), today announced that analyses from the global Phase 3 roxadustat clinical program will be presented at the American Society of Nephrology Kidney Week 2021 taking place virtually November 4 – 7, 2021. A total of 18 presentations will be presented by FibroGen, or its collaboration partners AstraZeneca and Astellas Pharma, Inc., at this year’s meeting. Eleven of the presentations are related to phase 3 studies of roxadustat for the treatment of anemia associated with CKD. An additional seven presentations are related to CKD anemia epidemiology and disease state which outline the burden of anemia on CKD patients and the continued unmet medical need for innovative therapies.
The accepted abstracts are now available on the ASN website at https://bit.ly/3FTP53Z
Roxadustat/CKD related poster presentations at ASN Kidney Week 2021:
| Presentation Title | Lead Author Presentation Details |
| Efficacy and Safety of Roxadustat in Patients with Anemia of Dialysis-Dependent CKD (DD-CKD) Treated Continuously for ≥3 Years AstraZeneca-sponsored | Hao, C.M. ePoster #: PO0450 |
| Efficacy and Safety of Roxadustat in Patients with Anemia of Non-Dialysis-Dependent CKD (NDD-CKD) Treated Continuously for ≥2 Years AstraZeneca-sponsored | Pecoits-Filho, R. ePoster #: PO0451 |
| Number Needed to Treat with Roxadustat to Avoid One Transfusion or Intravenous Iron Administration in Anemia of Non-Dialysis-Dependent CKD FibroGen-sponsored | Pecoits-Filho, R. ePoster #: PO0452 |
| Effects of Roxadustat in Patients with Dialysis-Dependent CKD (DD-CKD) Across All Baseline (BL) Hemoglobin (Hb) Values AstraZeneca-sponsored | Bhandari, S. ePoster #:PO0453 |
| Efficacy and Safety of Roxadustat in Patients with Anemia of Non-Dialysis- Across All Baseline (BL) Hemoglobin (Hb) Values AstraZeneca-sponsored | Pollock, C. ePoster #: PO0454 |
| Roxadustat in Elderly Patients with Anemia of CKD FibroGen-sponsored | Pollock, C. ePoster #: PO0455 |
| Roxadustat Effectively Treats Anemia in Dialysis-Dependent CKD (DD-CKD) Patients with Ferritin ≥500 ng/mL AstraZeneca-sponsored | Pergola, P. ePoster #: PO0456 |
| Associations Between Hepcidin and Laboratory Measures of Iron and Inflammation in Patients with Anemia and CKD Not on Dialysis in the Roxadustat Global Phase 3 Program FibroGen-sponsored | Fishbane, S ePoster #: PO0458 |
| Associations Between Hepcidin and Laboratory Measures of Iron and Inflammation in Incident Dialysis Patients with Anemia Enrolled in the Roxadustat Global Phase 3 Program FibroGen-sponsored | Provenzano, R. ePoster #: PO0459 |
| Estimating Long-Term Survival Rates in Patients with Anaemia of Non-Dialysis-Dependent CKD: An Expert Elicitation AstraZeneca-sponsored | Ouwens, M. ePoster #: PO0472 |
| Targeted Literature Review (TLR) Exploring Adherence to Treatments, with Potential to Extrapolate to Patients with Anemia of CKD Astellas-Sponsored | Alexandre, A. ePoster #: PO0481 |
| Weekly Risks of Death and Hospitalization Among Incident Patients Undergoing Dialysis AstraZeneca-sponsored | Weinhandl, E. ePoster #: PO0795 |
| Associations of Pre-Dialysis Care with Trajectories of Adverse Clinical Outcomes Among Patients Initiating Dialysis AstraZeneca-sponsored | Weinhandl, E. ePoster #: PO0807 |
| DENALI, a Phase 3b Multicenter, Open-Label Single-Arm Study of Roxadustat: Operational Learnings within US Dialysis Organizations FibroGen-sponsored | Silava, A. ePoster #: PO0940 |
| Prevalence of Inflammation and Associated Healthcare Resource Utilization in Patients with CKD FibroGen-sponsored | Lai, R. ePoster #: PO1751 |
| Health-Related Quality of Life in Patients with Inflammation and Non-Dialysis-Dependent CKD FibroGen-sponsored | Lai, R. ePoster #: PO2277 |
| A Machine Learning Algorithm to Identify Patients with Possible Non-Dialysis-Dependent CKD Astellas-Sponsored | Lobbedez, T. ePoster #: PO2340 |
| Efficacy and Safety of Roxadustat for the Treatment of Anemia of CKD in Patients Enrolled in the United States as Compared with the Global Cohort FibroGen-sponsored | Bansal, S. ePoster #: PO2367 |
About Anemia of CKD
Chronic kidney disease (CKD) is generally a progressive disease characterized by gradual loss of kidney function that may eventually lead to kidney failure or end stage renal disease, requiring dialysis or kidney transplant. CKD is estimated to occur in approximately 10-12% of adults worldwide and is predicted to become the fifth most common cause of premature death globally by 2040.
Anemia, a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin, is a common early complication of CKD, affecting approximately 20% of CKD patients. Anemia of CKD is associated with an increased risk of hospitalization, cardiovascular complications, and death, and can also cause significant fatigue, cognitive dysfunction and reduced quality of life. Blood transfusions are used for treating severe anemia, however, they may reduce a patient’s opportunity for kidney transplant and can increase the risk of infection and/or complications such as heart failure and allergic reactions.
About Roxadustat
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. Roxadustat is in clinical development for anemia of chronic kidney disease (CKD), anemia associated with myelodysplastic syndromes (MDS), and for chemotherapy-induced anemia (CIA).
Roxadustat is approved in European Union (EU) member states, including the European Economic Area (EEA) countries, as well as in Japan, China, Chile, and South Korea for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Several other licensing applications for roxadustat have been submitted by partners, Astellas and AstraZeneca to regulatory authorities across the globe, and are currently under review.
Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, other markets in the Americas, in Australia/New Zealand, and Southeast Asia.
About FibroGen
FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity for anemia associated with chronic kidney disease (CKD), anemia associated with myelodysplastic syndromes (MDS), and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD). FibroGen recently expanded its research and development portfolio to include product candidates in the immuno-oncology and autoimmune space. For more information, please visit www.fibrogen.com.
Forward-Looking Statements
This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company’s product candidates, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs. These include, the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and our Quarterly Report on Form 10-Q for quarter ended June 30, 2021 filed with the Securities and Exchange Commission (SEC), 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.
Contacts:
FibroGen, Inc.
Investors:
Michael Tung, MD
Corporate Strategy / Investor Relations
+1.415.978.1434
mtung@fibrogen.com
Media:
Meichiel Keenan
Public Affairs
mkeenan@fibrogen.com
