FibroGen to Present Safety and Efficacy Analyses from Roxadustat Global Phase 3 Program at American Society of Hematology Annual Meeting

Wednesday, 02. December 2020 13:00

New data show safety and efficacy of roxadustat in treating anemia secondary to lower-risk myelodysplastic syndromes (MDS) regardless of ring sideroblast (RS) or baseline erythropoietin level

Multiple analyses evaluate cardiovascular safety and efficacy of roxadustat in patients with anemia of chronic kidney disease (CKD) regardless of dialysis status 

SAN FRANCISCO, Dec. 02, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (Nasdaq: FGEN) and its partner, AstraZeneca (LSE/STO/Nasdaq: AZN), will present additional analyses of roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (MDS) and results from multiple roxadustat phase 3 studies. Roxadustat is a first-in-class oral small molecule hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) in development for the treatment of patients with anemia of CKD and anemia secondary to lower-risk MDS. FibroGen and its partner will present eight abstracts at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place virtually December 5-8, 2020.

“We are pleased to share additional 52-week data from the open-label portion of our Phase 3 anemia of MDS trial with the medical community at ASH,” said Enrique Conterno, Chief Executive Officer, FibroGen. “In addition, we are presenting Phase 3 cardiovascular safety and efficacy results of roxadustat, which highlight its potential in a broad range of CKD patients.”

MDS is a group of blood disorders characterized by poorly formed or dysfunctional blood cells, resulting in chronic anemia.1 Exploratory analyses to be presented at ASH show the efficacy of roxadustat in transfusion-dependent lower-risk MDS patients regardless of ring sideroblast and baseline erythropoietin status - characteristics used to predict response to treatment.2 Patients with ring sideroblasts (RS+), without ring sideroblasts (RS-), baseline erythropoietin (BL EPO) ≤ 200 mIU/ml, and BL EPO > 200 mIU/ml achieved the primary endpoint of transfusion independence for ≥ 8 weeks during the first 28 treatment weeks (23% of MDS-RS+, 55% of MDS-RS-, 39% of BL EPO ≤ 200 mIU/ml, and 33% of BL EPO > 200 mIU/ml patients). Detailed results will be presented at the meeting.

Enrollment in the double-blind placebo-controlled portion of the Phase 3 roxadustat study of patients with anemia secondary to lower-risk MDS is ongoing (NCT03263091).

Roxadustat presentations during the 62nd ASH Annual Meeting and Exposition:

PresenterPresentation titlePresentation details
David Henry, MDOral Roxadustat Demonstrates Efficacy in Anemia Secondary to Lower-Risk Myelodysplastic Syndrome Irrespective of Ring Sideroblasts and Baseline Erythropoietin LevelsePoster #1277
Session 637: Myelodysplastic Syndromes—Clinical Studies (Poster I)
Sat., Dec. 5: 7:00 AM–3:30 PM PT
Steven Fishbane, MDRoxadustat Lowers Risk of RBC Transfusion in Patients with Anemia of CKD

ePoster #748
Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster I)
Sat., Dec. 5: 7:00 AM–3:30 PM PT
Steven Fishbane, MDPooled Efficacy and Cardiovascular Safety Results of Roxadustat Compared with Epoetin Alfa in the Treatment of Anemia in Chronic Kidney Disease Patients on DialysisePoster #749
Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster I)
Sat., Dec. 5: 7:00 AM–3:30 PM PT
Carol Pollock, MDRoxadustat Increases Hemoglobin in Anemic Non-Dialysis-Dependent (NDD) Chronic Kidney Disease (CKD) Patients Independent of InflammationePoster #757
Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster I)
Sat., Dec. 5: 7:00 AM–3:30 PM PT
Roberto Pecoits-Filho, MDRoxadustat Treatment Results in Consistent Improvements in Hemoglobin (Hb) Versus Placebo: An Analysis of 3 Multinational RCTs in Patients with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)ePoster #758
Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster I)
Sat., Dec. 5: 7:00 AM–3:30 PM PT
Anjay Rastogi, MDRoxadustat Treatment Corrects Anemia to Hemoglobin (Hb) Values ≥10 g/dL in the Majority of Patients with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)ePoster #761
Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster I)
Sat., Dec. 5: 7:00 AM–3:30 PM PT
Steven Fishbane, MDHemoglobin (Hb) Correction with Roxadustat is Associated with Improved Iron Homeostasis in Patients with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)ePoster #766
Session 102: Regulation of Iron Metabolism (Poster I)
Sat., Dec. 5: 7:00 AM–3:30 PM PT
Robert Provenzano, MDPooled Efficacy and Cardiovascular Analysis of Roxadustat Compared with Placebo in Anemia Correction in Chronic Kidney Disease Patients Not on DialysisePoster #1671
Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster II)
Sun., Dec. 6: 7:00 AM–3:30 PM PT

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 MDS
MDS develops because the bone marrow cells do not develop into mature blood cells. Instead, these blood cells stay within the bone marrow in an immature state. There are many subtypes of MDS. Some cases are mild, while others are more severe, and carry a high risk of becoming acute myelogenous leukemia (AML). It is estimated that more than 10,000 patients are diagnosed with MDS each year in the U.S.,3 and overall prevalence is estimated to be between 60,000 – 170,000 in the country.4

About Roxadustat
Roxadustat is a first-in-class orally administered inhibitor of HIF-PH, which increases hemoglobin levels through a mechanism of action that is different from that of traditional erythropoiesis-stimulating agents. As a HIF-PH inhibitor, roxadustat activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood. Roxadustat promotes red blood cell production through increased endogenous production of erythropoietin; improved iron absorption, transport, and mobilization; and downregulation of hepcidin, which helps to overcome the negative impact of inflammation on hemoglobin synthesis and red blood cell production.

Roxadustat is approved and launched for the treatment of anemia of CKD in Japan and China in adult patients on dialysis (DD) and not on dialysis (NDD). A New Drug Application for the treatment of anemia of CKD in patients both DD and NDD is under review by the U.S. Food and Drug Administration with a decision expected in December 2020. The marketing authorization application for roxadustat for the treatment of anemia of CKD in patients both DD and NDD was accepted by the European Medicines Agency for review on May 21, 2020. Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, which are currently in 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 and other markets in the Americas and in Australia/New Zealand as well as 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). Roxadustat is also in clinical development for 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), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). 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, including 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, 2019 and our Quarterly Report on Form 10-Q for quarter ended September 30, 2020 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, M.D.
Investor Relations
+1.415.978.1434
mtung@fibrogen.com

Media:
Jennifer Harrington
+1.610.574.9196
Jennifer.Harrington@gcihealth.com


1 American Cancer Society. What Are Myelodysplastic Syndromes? Available at https://www.cancer.org/cancer/myelodysplastic-syndrome/about/what-is-mds.html. Accessed November 2020.
2 Abu-Zeinah G, DeSancho MT. Understanding Sideroblastic Anemia: An Overview of Genetics, Epidemiology, Pathophysiology and Current Therapeutic Options. J Blood Med. 2020;11:305-318. Published 2020 Sep 25. doi:10.2147/JBM.S232644
3 Ma X, Does M, Raza A, Mayne ST. Myelodysplastic syndromes: incidence and survival in the United States. Cancer. 2007;109(8):1536.
4 Cogle CR. Incidence and Burden of the Myelodysplastic Syndromes. Curr Hematol Malig Rep. 2015;10(3):272-281.


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