FibroGen, Inc. (NASDAQ:FGEN) announced data from three roxadustat
clinical trials, including the Phase 3 DOLOMITES study evaluating
roxadustat for treatment of anemia in non-dialysis-dependent CKD
patients compared to darbepoetin alfa, and ophthalmology findings
from a Japan Phase 3 study evaluating roxadustat compared to
darbepoetin alfa in patients on hemodialysis 1. These data were
presented in virtual oral sessions of the 57th European Renal
Association-European Dialysis and Transplant Association (ERA-EDTA)
Virtual Congress, taking place June 6 - 9, 2020. These trials were
conducted by Astellas Pharma, Inc., FibroGen’s collaboration
partner for roxadustat in Europe, Japan and certain other markets.
The Phase 3 DOLOMITES study evaluated the efficacy and safety of
roxadustat compared to darbepoetin alfa for the treatment of anemia
in non-dialysis dependent (NDD) patients with stage 3 - 5 chronic
kidney disease (CKD). In the primary endpoint analysis, the study
demonstrated non-inferiority of roxadustat to darbepoetin alfa in
the proportion of patients achieving correction of hemoglobin (Hb)
levels during the first 24 weeks of treatment (89.5% vs 78.0%; a
difference of 11.51% [95% confidence interval (CI): 5.66%,
17.36%]), with a lower bound of 95% confidence interval >0%. The
response in correction of hemoglobin levels was defined as
achieving Hb ≥11g/dL and Hb increase from baseline of ≥1g/dL with
baseline Hb >8g/dL, or Hb increase from baseline of ≥2.0 g/dL in
patients with baseline Hb ≤8.0 g/dL.
Secondary endpoints were hierarchically tested for
non-inferiority and superiority. Roxadustat was superior to
darbepoetin alfa in decreasing low-density lipoprotein cholesterol
with a least square mean (LSM) difference of -0.403 mmol/L (95% CI
-0.510, -0.296; [P<0.01]) and superior in time to first
intravenous iron use with a hazard ratio (HR) of 0.45 (95% CI:
0.26, 0.78; [P=0.004]). The non-inferiority of roxadustat to
darbepoetin alfa on hypertension risk was demonstrated for mean
arterial pressure change from baseline to weeks 12-28 with a LSM
difference of -0.372 mmHg (95% CI: -1.587, 0.842) and time to
occurrence of hypertension HR 0.83 (95% CI: 0.56, 1.22). Regarding
safety, the overall incidence of treatment-emergent adverse events
was comparable between roxadustat and darbepoetin alfa (91.6% and
92.5%, respectively).
With a relatively small sample size (roxadustat n=323,
darbepoetin n=293), non-confirmatory analysis of adjudicated major
adverse cardiovascular events (MACE), and MACE plus hospitalized
unstable angina and hospitalized congestive heart failure (MACE+)
outcomes showed HR point estimates of 0.81 (95% CI: 0.52, 1.25) and
0.90 (95% CI: 0.61, 1.32).
“The goal of treatment for anemia in CKD is to ensure sufficient
oxygenation to vital organs in the body. The vast majority of CKD
patients, however, continue to suffer from moderate to severe
anemia with low hemoglobin levels which are associated with a
higher risk of blood transfusions and with debilitating symptoms
that can make daily activities extremely challenging,” said K.
Peony Yu, M.D., Chief Medical Officer, FibroGen. “The results for
roxadustat presented at this year’s ERA-EDTA meeting represent the
breadth of our clinical development program and our commitment to
the continued evaluation of roxadustat as a potential treatment for
anemia in chronic kidney disease across a spectrum of patients and
treatment settings.”
“The DOLOMITES data adds to the comprehensive body of evidence
supporting the safety and efficacy of roxadustat in adult chronic
kidney disease patients with anemia who are non-dialysis dependent
(NDD),” said Enrique Conterno, Chief Executive Officer, FibroGen.
“The studies presented at the ERA-EDTA Virtual Congress 2020
reinforce our commitment to turning innovative science into valued
therapeutic medicines for patients.”
Ophthalmological effects of roxadustat from a Phase 3,
randomized, double-blind, active-comparator study in Japanese
patients on dialysis converted from ESA therapy (Study 1517-CL-307)
2 were also presented at the ERA-EDTA Virtual Congress 2020. The
primary endpoint of the study was achieved as roxadustat maintained
hemoglobin within 10–12 g/dL in patients on hemodialysis and was
non-inferior to darbepoetin alfa. Treatment-emergent adverse events
were consistent with previous reports and overall study results
were recently published in the Journal of the American Society of
Nephrology. This presentation at ERA-EDTA focused on a prospective
analysis of ophthalmological/retinal-related events observed during
this Phase 3 study. During the 24-week treatment period, these data
suggest that dialysis dependent CKD patients who were treated with
roxadustat were not at an increased risk of ophthalmic
abnormalities, compared with patients treated with darbepoetin
alfa. This includes retinal hemorrhages or increased retinal
thickness.
About the DOLOMITES Trial (Abstract
MO001)DOLOMITES is a Phase 3, randomized, open-label,
active-controlled study to evaluate the efficacy and safety of
roxadustat in comparison to darbepoetin alfa in the treatment of
anemia in adult NDD CKD patients. The study enrolled 616 adult
anemia patients with stage 3-5 CKD, of which 323 received
roxadustat and 293 received darbepoetin alfa. The response in
correction of hemoglobin levels was defined as achieving Hb ≥11g/dL
and Hb increase from baseline of ≥1g/dL with baseline Hb >8g/dL,
or Hb increase from baseline of ≥2.0 g/dL in patients with baseline
Hb ≤8.0 g/dL. For more information about this study, visit
www.clinicaltrials.gov [NCT02021318].
About Study 1517-CL-0307 (Abstract MO002)Study
1517-CL-0307 is a Phase 3, randomized, double-blind,
active-controlled clinical trial, conducted at 58 Japanese sites to
evaluate the non-inferiority of roxadustat to darbepoetin alfa when
both drugs are titrated to maintain Hb levels of 10-12g/dL in
Japanese CKD patients on hemodialysis. The study randomized 303
patients to receive either roxadustat (n=151) or darbepoetin alfa
(n=152) for 24 weeks. The safety of roxadustat was assessed by
monitoring treatment emergent adverse events and through detailed
ophthalmologic investigations, including adjudicated examination of
retinal vascular findings before and after treatment. For more
information about this study, visit
www.clinicaltrials.gov. [NCT02952092].
About Anemia Associated with 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 worldwide3 and is predicted to become the fifth most common
cause of premature death globally by 2040.4
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,5 affecting approximately 20% of
CKD patients.6 Anemia in 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, orally administered small molecule HIF-PH inhibitor
that promotes erythropoiesis through increasing endogenous
production of erythropoietin, and improved iron absorption,
transport and mobilization. Roxadustat is approved in China for the
treatment of anemia in CKD patients on dialysis and patients not on
dialysis, and is approved in Japan for the treatment of anemia in
CKD patients on dialysis, and a supplemental NDA for the treatment
of anemia in CKD patients not on dialysis is under regulatory
review. The roxadustat NDA for the treatment of anemia in CKD 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 in CKD 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 for
chemotherapy-induced anemia.
Astellas and FibroGen are collaborating on the development and
commercialization of roxadustat for the treatment of anemia in
territories including Japan and Europe. 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.
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 to treat 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. Pamrevlumab,
an anti-CTGF human monoclonal antibody, is in clinical development
for the treatment of idiopathic pulmonary fibrosis (IPF), locally
advanced unresectable pancreatic cancer, and Duchenne muscular
dystrophy (DMD). 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 March 31, 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.
Media: Sara Iacovino 1.703.474.4452
sara.iacovino@gcihealth.com
Investors: Michael Tung, M.D. Investor
Relations 1.415.978.1434 ir@fibrogen.com
References
- Clinicaltrials.gov. Roxadustat in the Treatment of Anemia in
Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in
Comparison to Darbepoetin Alfa (Dolomites). Available from:
https://clinicaltrials.gov/ct2/show/NCT02021318 [Last
accessed: June 2020].
- Clinicaltrials.gov. A Phase 3, Multi-center, Randomized, 2-arm
Parallel, Double-blind, Active-comparator (Darbepoetin Alfa)
Conversion Study of Intermittent Oral Dosing of ASP1517 in
Hemodialysis Chronic Kidney Disease Patients with Anemia. Available
from: https://clinicaltrials.gov/ct2/show/NCT02952092 [Last
accessed: June 2020].
- International Society of Nephrology. Chronic kidney
disease. Global kidney health atlas. Available
from: www.theisn.org/global-atlas [Last accessed: January
2020].
- Institute for Health Metrics and Evaluation
(IHME). Findings from the Global Burden of Disease Study
2017. Seattle, WA: IHME, 2018. Available
from: http://www.healthdata.org/sites/default/files/files/policy_report/2019/GBD_2017_Booklet.pdf [Last
accessed: January 2020].
- McClellan W, Aronoff SL, Bolton WK, et al. The prevalence of
anemia in patients with chronic kidney disease. Curr Med
Res Opin 2004;20:1501–1510.
- Dmitrieva O, de Lusignan S, Macdougall IC, et al. Association
of anaemia in primary care patients with chronic kidney disease:
cross sectional study of quality improvement in chronic kidney
disease (QICKD) trial data. BMC Nephrol 2013;14:24.
FibroGen (NASDAQ:FGEN)
Historical Stock Chart
From Aug 2024 to Sep 2024
FibroGen (NASDAQ:FGEN)
Historical Stock Chart
From Sep 2023 to Sep 2024