FibroGen Announces China FDA Approval of CTA to Conduct Pivotal Phase 2/3 Clinical Trial of Roxadustat in Anemia Associated W...
March 31 2017 - 7:05AM
FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical
company, today announced the approval by the China Food and Drug
Administration (CFDA) of the Company’s clinical trial application
(CTA) in China for a Phase 2/3 pivotal trial of roxadustat in
anemia associated with lower risk myelodysplastic syndromes (MDS).
FibroGen and AstraZeneca (NYSE:AZN) are collaborating on the
development and commercialization of roxadustat in China, the U.S.,
and other major markets. FibroGen is conducting all clinical trials
and regulatory submissions in both the U.S. and China, and will
retain all regulatory licenses and manufacturing permits in China.
This Phase 2/3 clinical trial will evaluate the safety and
efficacy of roxadustat in non-transfusion dependent, lower risk MDS
patients with anemia. The initial open-label portion of the study
is expected to enroll up to 40 patients, with 135 patients planned
for the randomized, double-blind, placebo-controlled Phase 3
portion of the study, in which subjects will be randomized 2:1 to
receive roxadustat or placebo three-times-weekly (TIW) for 26
weeks. The Company expects to initiate this Phase 2/3 study in the
second half of 2017.
In addition, the Company anticipates initiating a U.S. Phase 3
MDS clinical trial in the third quarter of 2017. The pivotal U.S.
study is a randomized, double-blind, placebo-controlled study
designed to evaluate the efficacy and safety of roxadustat for the
treatment of anemia in transfusion-dependent lower risk MDS
patients.
About MDS Anemia in ChinaMyelodysplastic
syndromes (MDS) are a group of disorders characterized by poorly
formed or dysfunctional blood cells, leading to anemia in most
patients. Anemia is associated with increased risk of
hospitalization, cardiovascular complication, need for blood
transfusion, exacerbation of other serious medical conditions, and
death. In addition, anemia frequently leads to significant fatigue,
cognitive dysfunction, and decreased quality of life. Currently,
there is no medicine approved for treating anemia in MDS in China.
MDS patients typically rely on repeated blood transfusions;
however, in China, due to limited blood supply and challenges in
accessing transfusions, anemia in most MDS patients is
undertreated.
About RoxadustatRoxadustat (FG-4592) is a
first-in-class, orally administered small molecule 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 in clinical trials 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.
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. To date, roxadustat
has been evaluated in Phase 1 and Phase 2 studies, involving more
than 1,400 subjects. Globally, a total of 15 Phase 3 studies, with
target enrollment of about 10,000 patients worldwide, are currently
being conducted 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. Roxadustat is
also entering a Phase 3 clinical trial in the U.S., and a Phase 2/3
in China for treatment of anemia in patients with myelodysplastic
syndromes (MDS). For information about roxadustat studies currently
recruiting patients, please visit www.clinicaltrials.gov.
About FibroGen, Inc. FibroGen, Inc.,
headquartered in San Francisco with subsidiary offices in Beijing
and Shanghai, is a leading science-based biopharmaceutical company
discovering and developing a pipeline of first-in-class
therapeutics. The company applies its pioneering expertise in
fibrosis and hypoxia-inducible factor (HIF) biology and clinical
development to advance innovative medicines for the treatment of
anemia, fibrotic disease, and cancer. Roxadustat (FG-4592), the
company’s most advanced product candidate, is an oral small
molecule inhibitor of HIF prolyl hydroxylase activity in Phase 3
clinical development for the treatment of anemia in chronic kidney
disease (CKD), and is entering Phase 3 development for anemia in
lower risk myelodysplastic syndromes (MDS). Pamrevlumab
(FG-3019), a fully-human monoclonal antibody that inhibits the
activity of connective tissue growth factor (CTGF), is in
Phase 2 clinical development for the treatment of idiopathic
pulmonary fibrosis (IPF), pancreatic cancer, and 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 candidate, roxadustat, in China, the
potential safety and efficacy profile of roxadustat, including in
anemia associated with myelodysplastic syndromes, the potential for
regulatory submissions, and our clinical plans, including timing
for planned initiation of clinical trials in China and the U.S. 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 non-clinical
and clinical programs, including enrollment and conduct of our
clinical trials, and our collaboration partners’ clinical trials
for roxadustat in anemia associated with CKD, the continued
progress of our plans and programs in China, including clinical
development of and regulatory filing outcomes for anemia associated
with myelodysplastic syndromes, and other matters that are
described in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2016, 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.
Contact
Karen L. Bergman
FibroGen, Inc.
VP, Investor Relations and Corporate Communications
+1 (415) 978-1433
kbergman@fibrogen.com
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