Roxadustat Phase 3 Clinical Results in
Late-Breaking Clinical Trial Posters and Oral
Presentation
FibroGen, Inc. (NASDAQ: FGEN), a leading
biopharmaceutical company discovering and developing a pipeline of
first-in-class therapeutics, today announced that results of four
Phase 3 clinical trials of roxadustat in anemia of chronic kidney
disease (CKD) will be presented at the American Society of
Nephrology (ASN) Kidney Week 2018 annual meeting in San Diego,
California from October 23-28, 2018.
Roxadustat is a first-in-class oral hypoxia-inducible factor
prolyl hydroxylase inhibitor (HIF-PHI) in late-stage development
for the treatment of anemia associated with CKD both in patients on
dialysis and in patients not on dialysis. Roxadustat is being
developed globally by FibroGen and its collaboration partners,
AstraZeneca AB and Astellas Pharma Inc.
Details for the presentations follow. Studies conducted in China
for China approval are noted by (*) and studies conducted in Japan
and for the Japan approval are noted by (**)
Late-Breaker Clinical Trial Poster
Presentations
Thursday, October 25, 2018 10:00 AM - 12:00 PM
PTSession: Late-Breaking Clinical Trial
PostersLocation: Exhibit Hall
- Phase 3, Randomized, Double-Blind, Active-Comparator
(Darbepoetin Alfa) Conversion Study of Oral Roxadustat in CKD
Patients with Anemia on Hemodialysis in Japan (Abstract
#TH-PO1151)**
- A Phase 3, Randomized, Open-Label, Active-Controlled Study of
Efficacy and Safety of Roxadustat for Treatment of Anemia in
Subjects with CKD on Dialysis (Abstract #TH-PO1152)*
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
of Efficacy and Safety of Roxadustat (FG-4592) for Treatment of
Anemia in Subjects with CKD Not on Dialysis (Abstract
#TH-PO1153)*
Oral Presentation
Saturday, October 27, 2018 5:54 PM - 6:06 PM
PTSession: Improving Dialysis Delivery and Patient
Outcomes (Session hours: 4:30 PM - 6:30 PM
PT)Location: Room 2, San Diego Convention
Center
- Phase 3, Multicenter, Open-Label Study of Intermittent Oral
Roxadustat in Peritoneal Dialysis CKD Patients with Anemia
(Abstract # SA-OR075)**
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.
FibroGen and collaboration partners are pursuing four approval
pathways in major jurisdictions to prepare for commercialization
worldwide:
- 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.
FibroGen and its partners have completed 35 Phase 1 and Phase 2
studies. The Phase 2 clinical studies have consistently
demonstrated anemia correction and maintenance of hemoglobin levels
in multiple subpopulations across a wide spectrum of CKD
patients.
Globally, the Phase 3 program encompasses a total of 15
Phase 3 studies of roxadustat in both non-dialysis-dependent
and dialysis-dependent CKD patients to support independent
regulatory approvals in the U.S., Europe, Japan, and China. To
date, positive topline results have been announced for seven of the
Phase 3 studies, with two supporting the China NDA for treatment of
anemia in CKD patients on dialysis and not on dialysis, four
supporting the Japan NDA for treatment of anemia in CKD patients on
dialysis, and one supporting the U.S./EU submissions. The China and
Japan NDAs are both under review by the respective regulatory
agencies.
Roxadustat is currently in Phase 3 clinical development for the
treatment of anemia associated with myelodysplastic syndromes (MDS)
in the U.S. and in Phase 2/3 development for MDS in China.
About FibroGen FibroGen, Inc., headquartered in
San Francisco, California, with subsidiary offices in Beijing and
Shanghai, People’s Republic of China, 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, completing worldwide Phase 3 clinical
development for the treatment of anemia in chronic kidney disease
(CKD), with a New Drug Application (NDA) currently under review by
the State Drug Administration (SDA) in China. Our partner
Astellas submitted a NDA for the treatment of anemia in CKD
patients on dialysis in Japan and currently under review by the
Pharmaceuticals and Medical Devices Agency (PMDA). Roxadustat is in
Phase 3 clinical development in the U.S. and Europe and in Phase
2/3 development in China 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 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 June 30, 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.
Investor and Media Contact Karen
L. Bergman Vice President, Investor Relations and Corporate
Communications FibroGen, Inc. kbergman@fibrogen.com (415)
978-1433
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