FibroGen, Inc. (NASDAQ: FGEN) today announced positive topline
results from WHITNEY, the Company’s Phase 2 clinical study of
roxadustat, a first-in-class oral small molecule hypoxia-inducible
factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of
chemotherapy-induced anemia (CIA).
WHITNEY is a Phase 2, open label study investigating the
efficacy and safety of roxadustat for treatment of anemia in
patients receiving concurrent chemotherapy treatment for
non-myeloid malignancies. The primary efficacy endpoint of maximum
change in hemoglobin within 16 weeks from baseline without red
blood cell transfusion was met.
“Roxadustat is a promising new approach for treating
chemotherapy induced anemia, which complicates the treatment of
many cancer patients,” said Mark D. Eisner, MD, MPH, Chief Medical
Officer, FibroGen. “Further studies will be necessary to evaluate
whether roxadustat can effectively and safely treat this important
type of anemia.”
In WHITNEY, ninety-two patients with non-myeloid malignancy
(solid tumor) having a hemoglobin level at or below 10 g/dL were
enrolled. Patients received a starting roxadustat dose of 2.0 mg/kg
or 2.5 mg/kg, three times per week (TIW), during a treatment period
of 16 weeks, with an additional 4-week follow-up period. Doses
could be titrated every 4 weeks.
Roxadustat was generally well tolerated and there were no
substantive differences in treatment-emergent adverse events
(TEAEs) between arms with different starting doses.
The full results of the study will be presented at a medical
meeting later this year.
For more information regarding this study, please visit
www.clinicaltrials.gov (NCT04076943).
About Chemotherapy-Induced AnemiaAlthough
chemotherapy-induced anemia is one of the most common side effects
of chemotherapy, it is often not recognized and is frequently
undertreated. CIA can adversely affect long-term patient outcomes,
as the anemia limits both quality of life and efficacy of
chemotherapy treatment. The incidence and severity of CIA depends
on a variety of factors. This includes the type of cancer and the
treatment, including the type of chemotherapy, schedule, and
intensity of therapy. It also depends on whether the patient has
received prior myelosuppressive chemotherapy, radiation therapy, or
both. An estimated 30% to 90% of cancer patients receiving
chemotherapy develop anemia1. Approximately 650,000 cancer patients
undergo chemotherapy every year in the United States2.
About RoxadustatRoxadustat, an oral medication,
is the first in a new class of medicines comprising HIF-PH
inhibitors that promote erythropoiesis, or red blood cell
production, through increased endogenous production of
erythropoietin, improved iron absorption and mobilization, and
downregulation of hepcidin. Roxadustat is also in clinical
development for anemia of chronic kidney disease (CKD) and anemia
associated with myelodysplastic syndromes (MDS).
Roxadustat is approved in European Union (EU) member states,
including the European Economic Area (EEA) countries, as well as in
Japan, China, Chile and South Korea for the treatment of anemia of
CKD in adult patients on dialysis (DD) and not on dialysis (NDD).
Several other licensing applications for roxadustat have been
submitted by partners, Astellas and AstraZeneca to regulatory
authorities across the globe, and are currently under review.
Astellas and FibroGen are collaborating on the development and
commercialization of roxadustat for the potential treatment of
anemia in territories including Japan, Europe, Turkey, Russia and
the Commonwealth of Independent States, the Middle East, and South
Africa. FibroGen and AstraZeneca are collaborating on the
development and commercialization of roxadustat for the potential
treatment of anemia in the U.S., China, other markets in the
Americas, in Australia/New Zealand, and Southeast Asia.
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 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 myelodysplastic syndromes (MDS) and for
chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human
monoclonal antibody, is in clinical development for the treatment
of locally advanced unresectable pancreatic cancer (LAPC), Duchenne
muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF).
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. These include, 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, 2020 and our Quarterly Report on Form 10-Q for
quarter ended June 30, 2021 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.
References:
- https://www.cdc.gov/cancer/preventinfections/providers.htm
- National Cancer Institute estimates of annual diagnoses from
2007 to 2011
Contacts:FibroGen, Inc.
Investors:Michael Tung, M.D.Corporate Strategy / Investor
Relations415.978.1434mtung@fibrogen.com
Media:GCI HealthFibroGenMedia@gcihealth.com
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