In non-dialysis and dialysis-dependent CKD patients, Major Adverse Cardiovascular Event (MACE) and MACE+ incidence rates were lowest when patients achieved hemoglobin levels ≥ 10 g/dL
Two analyses of pooled data from the roxadustat global Phase 3 development program to be presented during the American Society of Nephrology Kidney Week 2020 Reimagined
SAN FRANCISCO, Oct. 22, 2020 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ: FGEN) today announced results from two analyses of pooled data from the roxadustat global Phase 3 development program, examining associations between the achieved hemoglobin (Hb) levels and cardiovascular outcomes of both non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients with anemia of chronic kidney disease (CKD). Results of the analyses of three trials in NDD patients and three trials in DD patients, respectively, showed that Major Adverse Cardiovascular Events (MACE; all-cause mortality, myocardial infarction, and stroke) and MACE+ (MACE plus heart failure or unstable angina requiring hospitalization) rates were highest when Hb was less than 8 g/dL, decreased as Hb increased, and were lowest when Hb levels were greater than or equal to 10 g/dL.
These data (Abstracts PO2625 and PO2626) were accepted as late-breaking abstracts and will be featured in the Late-Breaking Clinical Trials Posters session at the American Society of Nephrology (ASN) Kidney Week 2020 Reimagined on October 22 at 10 AM.
“We have evidence that roxadustat is effective in increasing and maintaining hemoglobin levels in patients with anemia of chronic kidney disease, as shown across the roxadustat clinical program. These new post-hoc analyses showed that for patients who were treated with roxadustat, rates of cardiovascular events were lowest in patients when their hemoglobin levels were greater than 10 g/dL,” said Robert Provenzano, MD, Associate Professor of Medicine, Wayne State University, Detroit, Michigan, U.S. and a primary investigator in the roxadustat global Phase 3 program. “These additional safety results, coupled with roxadustat’s well-defined efficacy profile and its oral formulation, support the potential for roxadustat to become a safe and effective treatment option for anemia of chronic kidney disease, an area that has seen little therapeutic progress in the last 30 years.”
In both analyses, incidence rates of adjudicated MACE and MACE+ were evaluated based on Hb level immediately before the event. In the NDD CKD population, MACE and MACE+ rates were highest when Hb was less than 8 g/dL, decreased as Hb increased and were lowest when achieved Hb levels were greater than or equal to 10 g/dL.
| Parameter | Maximum Hemoglobin | |||||||
| < 8 g/dL |
8 – < 9 g/dL |
9 – < 10 g/dL |
10 – < 11 g/dL |
11 – < 12 g/dL |
≥ 12 g/dL | |||
| Outcome | Time point | Event rate/100 PEY (95% CI) | ||||||
| MACE | Immediately before event |
60.9 | 25.6 | 16.2 | 7.1 | 4.9 | 6.7 | |
| MACE+ | Immediately before event |
82.9 | 35.0 | 21.5 | 10.4 | 6.8 | 9.7 | |
| PEY | 59.1 | 179.9 | 501.4 | 1189.8 | 1417.4 | 690.0 | ||
PEY: patient-exposure years
Similarly, in the DD CKD population, MACE and MACE+ rates were highest when Hb was less than 8 g/dL, decreased as Hb increased and were lowest when achieved Hb levels were greater than or equal to 10 g/dL.
| Parameter | Maximum Hemoglobin | |||||||
| < 8 g/dL | 8 – < 9 g/dL |
9 – < 10 g/dL |
10 – < 11 g/dL |
11 – < 12 g/dL |
≥ 12 g/dL | |||
| Outcome | Time point | Event rate/100 PEY (95% CI) | ||||||
| MACE | Immediately before event |
59.4 | 23.0 | 17.4 | 10.6 | 9.4 | 7.2 | |
| MACE+ | Immediately before event |
65.7 | 29.9 | 25.2 | 13.5 | 11.5 | 9.8 | |
| PEY | 63.9 | 173.8 | 464.7 | 1055.1 | 1149.8 | 539.4 | ||
PEY: patient-exposure years
“Anemia typically develops in patients with chronic kidney disease and worsens as the disease progresses, decreasing oxygenation and resulting in an increased risk of cardiovascular complications and death,” said Peony Yu, M.D., Chief Medical Officer, FibroGen. “We are delighted to be presenting these additional results that further demonstrate the potential of roxadustat to be a meaningful treatment option for chronic kidney disease patients with anemia.”
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 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 of adult patients with CKD, both on dialysis and not on dialysis. In Japan, roxadustat is approved for the treatment of anemia of CKD patients on dialysis, and a supplemental NDA for the treatment of anemia of CKD patients not on dialysis is under regulatory review. The roxadustat NDA for the treatment of anemia of 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 of 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, M.D.
Investor Relations
+1.415.978.1434
mtung@fibrogen.com
Media:
Jennifer Harrington
+1.610.574.9196
Jennifer.Harrington@gcihealth.com
