FibroGen, Inc. (Nasdaq: FGEN) and its partners, AstraZeneca
(LSE/STO/Nasdaq: AZN) and Astellas Pharma Inc. (TSE: 4503), will
present new analyses from the global Phase 3 program at the
upcoming American Society of Nephrology (ASN) Kidney Week 2020
Reimagined, assessing the potential of roxadustat, a first-in-class
orally-administered hypoxia-inducible factor prolyl hydroxylase
(HIF-PH) inhibitor, to revolutionize the treatment of anemia in
patients with chronic kidney disease (CKD). The virtual congress
will take place October 22-25, 2020. FibroGen and its partners will
present 42 abstracts, including 2 late-breaker poster
presentations, and 10 which have been accepted for oral
presentation.
Twenty-eight presentations on roxadustat for the treatment of
anemia associated with CKD will further demonstrate the depth and
breadth of the roxadustat global Phase 3 development program and
build on the known clinical profile of roxadustat in treating a
broad spectrum of CKD patients. Another 12 presentations on CKD
anemia epidemiology and disease state outline the burden of anemia
on CKD patients and their unmet medical need for innovative
therapies. In addition, two late-breaking poster presentations will
explore associations between cardiovascular safety and hemoglobin
levels achieved with roxadustat in both non-dialysis-dependent
(NDD) and dialysis-dependent (DD) CKD patients.
“Our roxadustat clinical data at ASN Kidney Week 2020 Reimagined
demonstrate consistent efficacy and positive safety results across
the continuum of chronic kidney disease patients with anemia,
adding to the established body of evidence highlighting roxadustat
as a potential foundational treatment for this condition affecting
millions of patients,” said Enrique Conterno, Chief Executive
Officer, FibroGen. “We thank the investigators, study site staff,
and patients who participated in the global roxadustat development
program.”
Abstracts assessing the potential clinical profile for use of
roxadustat for anemia treatment in CKD patients will include:
- Red Blood Cell
(RBC)
Transfusion
ReductionAbstracts on the
potential of roxadustat to reduce the need for RBC transfusions
across the continuum of patients with anemia in CKD include:
Lead Author |
Abstract # / Presentation Title |
Presentation Details |
Daniel Coyne, MD |
Abstract PO0261: Risk of Transfusion in Patients with
Non-Dialysis-Dependent CKD Increases with Hemoglobin Levels <10
g/dL vs. ≥10 g/dL: Pooled Results from Roxadustat Phase 3
StudiesFibroGen-sponsored |
Poster Session: Anemia and Iron Management October 22, On-Demand 10
AM-12 PM |
Robert Provenzano, MD |
Abstract PO0268: Risk of Transfusion in Patients with
Dialysis-Dependent CKD Increases with Hemoglobin Levels <10 g/dL
vs. ≥10 g/dL: Pooled Results from Roxadustat Phase 3
StudiesFibroGen-sponsored |
Poster Session: Anemia and Iron Management October 22, On-Demand 10
AM-12 PM |
Anjay Rastogi, MD |
Abstract PO0264: 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)AstraZeneca-sponsored |
Poster Session: Anemia and Iron Management October 22, On-Demand 10
AM-12 PM |
- Congestive Heart
Failure (CHF)
HospitalizationAbstract comparing the rates of
hospitalization due to CHF, a common and serious comorbidity in CKD
patients, between roxadustat and comparators:
Lead Author |
Abstract # / Presentation Title |
Presentation Details |
Robert Provenzano, MD |
Abstract SA-OR39: Pooled Analyses of the Phase 3 Roxadustat
Studies: Congestive Heart Failure Hospitalization Rates in Dialysis
and Non-Dialysis Patients with Anemia Treated with Roxadustat vs.
ComparatorsFibroGen-sponsored |
Poster Session: Hypertension and Vascular Disease: From the Lab to
TrialsOctober 24, Simulive5-7 PM |
- Additional SafetyAbstracts
addressing the safety profile of roxadustat include:
Lead Author |
Abstract # / Presentation Title |
Presentation Details |
Daniel Coyne, MD |
Abstract TH-OR04: Roxadustat Is Not Associated with An Increased
Risk of Neoplasm in Patients with CKD and Anemia
FibroGen-sponsored |
Poster Session: Breakthroughs in Anemia and Iron ManagementOctober
22, Simulive5-7PM |
Tak Mao Daniel Chan, MD |
Abstract PO2114: Roxadustat vs. Placebo or Epoetin-alfa Has No
Clinically Meaningful Effect on Blood Pressure in Patients with
Anemia of CKDFibroGen-sponsored |
Poster Session: CVD, BP and Kidney Diseases: Exploring the
LinkOctober 22, On-Demand 10 AM-12 PM |
Quan Dong Nguyen, MD |
Abstract PO0267: Ophthalmological Effects of Roxadustat in the
Treatment of Anemia in Dialysis-Dependent and
Non–Dialysis-Dependent CKD Patients: Findings from Two Phase 3
StudiesAstellas-sponsored |
Poster Session: Anemia and Iron Management October 22, On-Demand 10
AM-12 PM |
- Efficacy and SafetyAbstracts building on the
known efficacy and safety profile of roxadustat for treatment of
anemia across the continuum of CKD severity in patient subgroups
with different comorbidities, dialysis status or dialysis modality
in both NDD and DD CKD, include:
Lead Author |
Abstract # / Presentation Title |
Presentation Details |
In
Non-Dialysis-Dependent
Patients (placebo-controlled studies: OLYMPUS, ANDES,
ALPS) |
Daniel Coyne, MD |
Abstract PO0260: Subgroup Analyses of Efficacy of Roxadustat for
Treatment of Anemia in Patients with Non-Dialysis-Dependent
CKDFibroGen-sponsored |
Poster Session: Anemia and Iron Management October 22, On-Demand 10
AM-12 PM |
Simon Roger, MD |
Abstract PO1032: Efficacy and Safety of Roxadustat in Patients with
Non–Dialysis-Dependent CKD, Anemia, and Diabetes
MellitusFibroGen-sponsored |
Poster Session: Diabetic Kidney Disease: Clinical - 2October 22,
On-Demand 10 AM-12 PM |
Simon Roger, MD |
Abstract PO2111: Efficacy and Safety of Roxadustat in Patients with
Non-Dialysis-Dependent CKD, Anemia, and Heart
FailureFibroGen-sponsored |
Poster Session: CVD, BP and Kidney Diseases: Exploring the Link
October 22, On-Demand 10 AM-12 PM |
Roberto Pecoits-Filho, MD |
Abstract TH-OR05: Roxadustat Treatment Results in Consistent
Improvements in Hemoglobin (Hb) vs. Placebo: An Analysis of Three
Multinational Randomized Clinical Trials in Patients with
Non-Dialysis-Dependent CKD (NDD-CKD)AstraZeneca-sponsored |
Poster Session: Breakthroughs in Anemia and Iron ManagementOctober
22, Simulive5-7 PM |
In Dialysis-Dependent
Patients (epoetin alfa controlled studies:
ROCKIES, SIERRAS, HIMALAYAS) |
Tak Mao Daniel Chan, MD |
Abstract SU-OR24: Efficacy and Safety of Roxadustat in Patients
with Dialysis-Dependent CKD and Anemia on Peritoneal
DialysisFibroGen-sponsored |
Poster Session: Peritoneal Dialysis and Vascular Access: Research
AbstractsOctober 25, Simulive5-7 PM |
Daniel Coyne, MD |
Abstract PO2112: Efficacy and Safety of Roxadustat in Patients with
Dialysis-Dependent CKD, Anemia, and Heart
FailureFibroGen-sponsored |
Poster Session: CVD, BP and Kidney Diseases: Exploring the
LinkOctober 22, On-Demand 10 AM-12 PM |
Robert Provenzano, MD |
Abstract PO0259: Subgroup Analyses of Efficacy of Roxadustat for
Treatment of Anemia in Patients with Incident Dialysis-Dependent
CKDFibroGen-sponsored |
Poster Session: Anemia and Iron Management October 22, On-Demand 10
AM-12 PM |
Tak Mao Daniel Chan, MD |
Abstract PO1031: Efficacy and Safety of Roxadustat in Patients with
Dialysis-Dependent CKD, Anemia, and Diabetes
MellitusFibroGen-sponsored |
Poster Session: Diabetic Kidney Disease: Clinical - 2October 22,
On-Demand 10 AM-12 PM |
Robert Provenzano, MD |
Abstract FR-OR25: Efficacy and Safety of Roxadustat in Patients
with Dialysis-Dependent CKD and Anemia on
HemodialysisFibroGen-sponsored |
Poster Session: Hemodialysis and Home Hemodialysis: Research
AbstractOctober 23, Simulive5-7 PM |
- Efficacy and Safety of
Roxadustat Versus
Darbepoetin AlfaAbstract
on the primary results of a clinical trial on efficacy and safety
of roxadustat in comparison to darbepoetin alfa in non-dialysis
dependent patients (DOLOMITES):
Lead Author |
Abstract # / Presentation Title |
Presentation Details |
Jonathan Barratt, MD |
Abstract TH-OR02: Roxadustat for the Treatment of Anemia in CKD
Patients Not on Dialysis (NDD): A Phase 3, Randomized, Open-label,
Active-controlled Study Astellas-sponsored |
Poster Session: Breakthroughs in Anemia and Iron Management October
22, Simulive 5-7 PM |
- Inflammation and
IronAbstracts assessing roxadustat efficacy
regardless of inflammation status as well as impact on iron
homeostasis:
Lead Author |
Abstract # / Presentation Title |
Presentation Details |
In
Non-Dialysis-Dependent
Patients (placebo-controlled studies: OLYMPUS, ANDES,
ALPS) |
Daniel Coyne, MD |
Abstract PO0262: Roxadustat Favorably Modifies Iron Indices in
Patients with Non-Dialysis-Dependent CKD-related
AnemiaFibroGen-sponsored |
Poster Session: Anemia and Iron Management October 22, On-Demand 10
AM-12 PM |
Carol Pollock, MD |
Abstract PO0263: Roxadustat Increases Hemoglobin in Anemic
Non-Dialysis-Dependent (NDD) CKD Patients Independent of
InflammationAstraZeneca-sponsored |
Poster Session: Anemia and Iron Management October 22, On-Demand 10
AM-12 PM |
Steven Fishbane, MD |
Abstract PO0257: Hemoglobin (Hb) Correction with Roxadustat is
Associated with Improved Iron Homeostasis in Patients with
Non-Dialysis-Dependent CKD (NDD-CKD)AstraZeneca-sponsored |
Poster Session: Anemia and Iron ManagementOctober 22, On-Demand10
AM-12 PM |
In Dialysis-Dependent
Patients (epoetin alfa controlled studies:
ROCKIES, SIERRAS, HIMALAYAS) |
Mohamed El-Shahawy, MD |
Abstract PO0265: Roxadustat Increases Hemoglobin in Anemic
Dialysis-Dependent (DD) CKD Patients Independent of
InflammationAstraZeneca-sponsored |
Poster Session: Anemia and Iron Management October 22, On-Demand 10
AM-12 PM |
Pablo Pergola, MD |
Abstract TH-OR06: Hemoglobin (Hb) Correction with Roxadustat Is
Associated with Improved Iron Homeostasis in Patients with
Dialysis-Dependent CKD (DD-CKD)AstraZeneca-sponsored |
Poster Session: Breakthroughs in Anemia and Iron ManagementOctober
22, Simulive5-7 PM |
About Anemia Associated with 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 in 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 RoxadustatRoxadustat is a first-in-class,
oral small molecule HIF-PH inhibitor that promotes erythropoiesis
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 in China for the treatment of anemia in
adult patients with CKD, both on dialysis and not on dialysis. In
Japan, roxadustat is approved for the treatment of anemia in CKD
patients on dialysis, and a supplemental NDA for the treatment of
anemia in CKD patients not on dialysis is under regulatory review.
The roxadustat NDA for the treatment of anemia in CKD in patients
both on dialysis and not on dialysis is under review by the U.S.
Food and Drug Administration with a Prescription Drug User Fee Act
date of December 20, 2020. The Marketing Authorization Application
for roxadustat for the treatment of anemia in CKD in patients both
on dialysis and not on dialysis was filed by our partner Astellas
and accepted by the European Medicines Agency for review on
May 21, 2020. Roxadustat is also in clinical development for
anemia associated with myelodysplastic syndromes (MDS) and
chemotherapy-induced anemia (CIA).
Astellas and FibroGen are collaborating on the development and
commercialization of roxadustat for the treatment of anemia in
territories including Japan, Europe, the Commonwealth of
Independent States, the Middle East, and South Africa. AstraZeneca
and FibroGen are collaborating on the development and
commercialization of roxadustat for the treatment of anemia in the
U.S., China, and other markets in the Americas and in Australia/New
Zealand, as well as Southeast Asia. At ASN Kidney Week 2020
Reimagined, roxadustat data will be sponsored and presented by
Astellas, AstraZeneca, and FibroGen.
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 June 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, MDCorporate Strategy /
Investor Relations+1.415.978.1434mtung@fibrogen.com
Media
Inquiries:Jennifer
Harrington+1.610.574.9196jennifer.harrington@gcihealth.com
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