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 |
|
|
< 8g/dL |
8 - < 9g/dL |
9 - < 10g/dL |
10 - < 11g/dL |
11 - < 12g/dL |
≥ 12 g/dL |
Outcome |
Time point |
Event rate/100 PEY (95% CI) |
|
MACE |
Immediatelybefore event |
60.9 |
25.6 |
16.2 |
7.1 |
4.9 |
6.7 |
MACE+ |
Immediatelybefore 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 - < 9g/dL |
9 - < 10g/dL |
10 - < 11g/dL |
11 - < 12g/dL |
≥ 12 g/dL |
Outcome |
Time point |
Event rate/100 PEY (95% CI) |
|
MACE |
Immediatelybefore event |
59.4 |
23.0 |
17.4 |
10.6 |
9.4 |
7.2 |
MACE+ |
Immediatelybefore 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 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 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 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 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, M.D.Investor
Relations+1.415.978.1434mtung@fibrogen.com
Media:Jennifer Harrington
+1.610.574.9196Jennifer.Harrington@gcihealth.com
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