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:
Presenter |
Presentation title |
Presentation details |
David Henry, MD |
Oral Roxadustat Demonstrates Efficacy in Anemia Secondary to
Lower-Risk Myelodysplastic Syndrome Irrespective of Ring
Sideroblasts and Baseline Erythropoietin Levels |
ePoster #1277Session 637: Myelodysplastic Syndromes—Clinical
Studies (Poster I)Sat., Dec. 5: 7:00 AM–3:30 PM PT |
Steven Fishbane, MD |
Roxadustat Lowers Risk of RBC Transfusion in Patients with Anemia
of CKD |
ePoster #748Session 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, MD |
Pooled Efficacy and Cardiovascular Safety Results of Roxadustat
Compared with Epoetin Alfa in the Treatment of Anemia in Chronic
Kidney Disease Patients on Dialysis |
ePoster #749Session 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, MD |
Roxadustat Increases Hemoglobin in Anemic Non-Dialysis-Dependent
(NDD) Chronic Kidney Disease (CKD) Patients Independent of
Inflammation |
ePoster #757Session 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, MD |
Roxadustat 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 #758Session 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, MD |
Roxadustat 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 #761Session 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, MD |
Hemoglobin (Hb) Correction with Roxadustat is Associated with
Improved Iron Homeostasis in Patients with Non-Dialysis-Dependent
Chronic Kidney Disease (NDD-CKD) |
ePoster #766Session 102: Regulation of Iron Metabolism (Poster
I)Sat., Dec. 5: 7:00 AM–3:30 PM PT |
Robert Provenzano, MD |
Pooled Efficacy and Cardiovascular Analysis of Roxadustat Compared
with Placebo in Anemia Correction in Chronic Kidney Disease
Patients Not on Dialysis |
ePoster #1671Session 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
CKDChronic 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 MDSMDS 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 RoxadustatRoxadustat 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 FibroGenFibroGen, 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 StatementsThis 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+1.415.978.1434mtung@fibrogen.com
Media:Jennifer
Harrington+1.610.574.9196Jennifer.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.S2326443 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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