FibroGen to Present New Efficacy and Safety Analyses from Roxadustat Global Phase 3 Program at American Society of Nephrology Kidney Week 2020 Reimagined

Rhea-AI Summary

FibroGen is set to present new findings on roxadustat at the ASN Kidney Week 2020, highlighting its efficacy in treating anemia in patients with chronic kidney disease (CKD). The studies will explore various patient demographics, including dialysis-dependent and non-dialysis-dependent groups, and will address the safety profile regarding cardiovascular risks and hospitalizations. The data suggests potential reductions in the need for red blood cell transfusions and emphasizes roxadustat's promise as a foundational treatment option for CKD-related anemia.

Positive

• Roxadustat shows consistent efficacy in treating anemia across diverse CKD patient groups.
• Potential reduction in the need for RBC transfusions highlighted in study results.
• Research indicates no increased risk of neoplasms associated with roxadustat use.
• Data suggests a favorable safety profile related to hypertension and ophthalmological effects.

Negative

• None.

Late-breaking abstracts explore cardiovascular outcomes of patients with anemia in chronic kidney disease (CKD) treated with roxadustat, including associations with achieved hemoglobin levels and risk of Major Adverse Cardiovascular Events (MACE) and MACE+

New analyses evaluate efficacy of roxadustat across the continuum of patients with anemia in CKD – both on dialysis and not on dialysis – including different dialysis modalities, iron repletion status, and comorbidities.

Presentations address safety profile of roxadustat related to neoplasms, hypertension, and ophthalmological effects

Additional presentations explore increased risk of red blood cell transfusion at lower hemoglobin levels and impact of roxadustat on rates of hospitalization due to congestive heart failure

SAN FRANCISCO, Oct. 14, 2020 (GLOBE NEWSWIRE) -- 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 Reduction
  Abstracts 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 Studies FibroGen-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 Studies FibroGen-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) Hospitalization
  Abstract 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. Comparators FibroGen-sponsored	Poster Session: Hypertension and Vascular Disease: From the Lab to Trials October 24, Simulive 5-7 PM

• Additional Safety
  Abstracts 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 Management October 22, Simulive 5-7PM
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 CKD FibroGen-sponsored	Poster Session: CVD, BP and Kidney Diseases: Exploring the Link October 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 Studies Astellas-sponsored	Poster Session: Anemia and Iron Management October 22, On-Demand 10 AM-12 PM

• Efficacy and Safety
  Abstracts 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 CKD FibroGen-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 Mellitus FibroGen-sponsored	Poster Session: Diabetic Kidney Disease: Clinical - 2 October 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 Failure FibroGen-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 Management October 22, Simulive 5-7 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 Dialysis FibroGen-sponsored	Poster Session: Peritoneal Dialysis and Vascular Access: Research Abstracts October 25, Simulive 5-7 PM
Daniel Coyne, MD	Abstract PO2112: Efficacy and Safety of Roxadustat in Patients with Dialysis-Dependent CKD, Anemia, and Heart Failure FibroGen-sponsored	Poster Session: CVD, BP and Kidney Diseases: Exploring the Link October 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 CKD FibroGen-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 Mellitus FibroGen-sponsored	Poster Session: Diabetic Kidney Disease: Clinical - 2 October 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 Hemodialysis FibroGen-sponsored	Poster Session: Hemodialysis and Home Hemodialysis: Research Abstract October 23, Simulive 5-7 PM

• Efficacy and Safety of Roxadustat Versus Darbepoetin Alfa
  Abstract 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 Iron
  Abstracts 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 Anemia FibroGen-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 Inflammation AstraZeneca-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 Management October 22, On-Demand 10 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 Inflammation AstraZeneca-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 Management October 22, Simulive 5-7 PM

About Anemia Associated with 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 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 Roxadustat
Roxadustat 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 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 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, MD
Corporate Strategy / Investor Relations
+1.415.978.1434
mtung@fibrogen.com

Media Inquiries:
Jennifer Harrington
+1.610.574.9196
jennifer.harrington@gcihealth.com

FAQ

What are the key findings regarding roxadustat at ASN Kidney Week 2020?

Key findings include roxadustat's consistent efficacy across various CKD patient groups and its potential to reduce the need for red blood cell transfusions.

What is the safety profile of roxadustat as presented in the ASN Kidney Week 2020?

The safety profile of roxadustat indicates no increased risk of neoplasms and a manageable impact on blood pressure.

How does roxadustat compare to other treatments for anemia in CKD?

Roxadustat is being evaluated for its effectiveness against existing treatments, with promising data supporting its use as a foundational therapy.

What is the significance of the late-breaking presentations on roxadustat?

These presentations provide critical insights into the cardiovascular outcomes and overall efficacy of roxadustat in managing anemia in CKD patients.

What insights were shared about the treatment of anemia in both dialysis-dependent and non-dialysis-dependent CKD patients?

Findings address the efficacy of roxadustat in both populations, demonstrating its potential in various treatment scenarios.