FibroGen, Inc. (NASDAQ:FGEN), a biopharmaceutical company, today
announced the completion of patient enrollment in the Phase 3
studies supporting the U.S. new drug application (NDA) submission
for roxadustat in anemia associated with chronic kidney disease
(CKD). The Phase 3 clinical program is evaluating the use of
roxadustat for the treatment of anemia in both dialysis-dependent
and non-dialysis-dependent CKD patients.
“We are pleased to have achieved this critical step in our
roxadustat Phase 3 clinical program, and we look forward to
reporting topline results from these studies by the end of this
year, with pooled safety analyses available in 2019,” said K. Peony
Yu, Chief Medical Officer, FibroGen. “The results of these studies
will support the submission of an NDA in the first half of
2019.”
A total of approximately 9,000 CKD patients were enrolled across
the seven studies sponsored by FibroGen and its partners Astellas
Pharma Inc. and AstraZeneca in both dialysis-dependent patients and
non-dialysis-dependent patients. Subpopulations of interest include
patients initiating dialysis (incident dialysis) and patients with
inflammation.
Previously reported results from extensive Phase 2 studies and
Phase 3 studies from China and from Japan have shown roxadustat to
be effective in correcting and/or maintaining hemoglobin levels in
various populations of CKD patients with anemia. Roxadustat has
shown positive effects on iron metabolism, and the ability to
correct and maintain hemoglobin levels without requiring
concomitant administration of intravenous iron. Roxadustat has been
well-tolerated in all studies to date.
“This is an exciting time for us as we advance the first oral
therapy for anemia in CKD one step closer to patients,” said Thomas
B. Neff, Chief Executive Officer, FibroGen. “Our goal is to provide
these patients and those who care for them with a new therapeutic
option with the potential to be safer, more effective, more
convenient, and more accessible than currently available
therapies.”
About CKD and Anemia Anemia is a serious
medical condition in which patients have insufficient red blood
cells and low levels of hemoglobin (“Hb”), a protein in red blood
cells that carries oxygen to cells throughout the body. Anemia is
associated with increased risk of hospitalization, cardiovascular
complications, need for blood transfusion, exacerbation of other
serious medical conditions, and death. In addition, anemia
frequently causes significant fatigue, cognitive dysfunction, and
decreased quality of life. The more severe the anemia, as measured
by lower Hb levels, the greater the health impact on patients.
Severe anemia is common in patients with CKD, cancer, MDS,
inflammatory diseases, and other serious illnesses. Even when it
accompanies prevalent and serious diseases, anemia is often not
effectively treated.
Anemia is particularly prevalent in patients with CKD, which is
a critical healthcare problem in the U.S. and Europe, and most
commonly caused by diabetes and hypertension. CKD affects more than
200 million people worldwide and significantly increases
healthcare costs for those patients. CKD is generally a progressive
disease characterized by gradual loss of kidney function that may
eventually lead to kidney failure, which is also known as end-stage
renal disease (“ESRD”). Patients with ESRD require renal
replacement therapy — either dialysis treatment or kidney
transplantation. CKD accompanied by anemia is associated with worse
health outcomes than CKD alone, including more rapid disease
progression and an increased death rate. There are five stages
of CKD that are primarily defined by a measure of the filtration
function of the kidney (GFR).
In the U.S., according to the USRDS, a majority of dialysis
eligible CKD patients are currently on dialysis. Of the
approximately 475,000 patients receiving dialysis in the U.S.,
approximately 83% were being treated with ESAs for anemia. Despite
the presence of anemia in stages 3 and 4 CKD patients, in clinical
practice, patients typically do not receive ESA treatment for their
anemia until they initiate dialysis. As of 2014, approximately 14%
of U.S. NDD-CKD patients were being treated with ESAs prior to
initiation of dialysis (2016 USRDS ADR). In many CKD patients, the
disease progresses gradually over decades and patients can spend
years suffering from the symptoms and negative health effects of
anemia before they receive treatment. Many of these patients die
from cardiovascular events before they initiate dialysis.
About Roxadustat Roxadustat (FG-4592) is a
first-in-class, orally administered small molecule currently in
global Phase 3 clinical development as a potential therapy for
anemia associated with chronic kidney disease (CKD). Roxadustat is
a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
that promotes erythropoiesis through increasing endogenous
erythropoietin, improving iron regulation, and reducing hepcidin.
Administration of roxadustat has been shown to induce coordinated
erythropoiesis – increasing red blood cell count while maintaining
plasma erythropoietin levels within or near normal physiologic
range in multiple subpopulations of CKD patients, including in the
presence of inflammation and without a need for supplemental
intravenous iron.
Astellas and FibroGen are collaborating on the development and
commercialization of roxadustat for the treatment of anemia in
patients with CKD 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 patients with CKD in the U.S., China, and other
markets.
Roxadustat is currently advancing through Phase 3 clinical
trials worldwide, supported by extensive Phase 2 clinical data
demonstrating correction and maintenance of hemoglobin levels in
multiple subpopulations of CKD anemia patients. Globally, the Phase
3 program encompasses a total of 15 Phase 3 studies to support
independent regulatory approvals of roxadustat in both
non-dialysis-dependent and dialysis-dependent CKD patients in the
U.S., Europe, Japan, and China.
About FibroGen FibroGen, Inc., headquartered in
San Francisco, with subsidiary offices in Beijing and Shanghai, is
a leading biopharmaceutical company discovering and developing a
pipeline of first-in-class therapeutics. The company applies
its pioneering expertise in hypoxia-inducible factor (HIF),
connective tissue growth factor (CTGF) biology, and clinical
development to advance innovative medicines for the treatment of
anemia, fibrotic disease, and cancer. Roxadustat, the company’s
most advanced product candidate, is an oral small molecule
inhibitor of HIF prolyl hydroxylase activity in worldwide Phase 3
clinical development for the treatment of anemia in chronic kidney
disease (CKD), with a New Drug Application currently under review
in China by the State Drug Administration or SDA (formerly the
China Food and Drug Administration). Roxadustat is in Phase 3
clinical development in the U.S. and Europe for anemia associated
with myelodysplastic syndromes (MDS). Pamrevlumab, an
anti-CTGF human monoclonal antibody, is advancing towards Phase 3
clinical development for the treatment of idiopathic pulmonary
fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2
trial for Duchenne muscular dystrophy (DMD). FibroGen is also
developing a biosynthetic cornea in China. 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
of the company’s product candidates pamrevlumab and roxadustat, the
potential safety and efficacy profile of our product candidates,
and our clinical, regulatory, and commercial plans, 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, 2017, and our Quarterly Report on Form 10-Q for
the fiscal quarter ended March 31, 2018 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.
ContactFibroGen, Inc.Karen L.
BergmanVice President, Investor Relations and Corporate
Communications1 (415) 978-1433kbergman@fibrogen.com
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