FibroGen, Inc. (NASDAQ: FGEN) today announced dosing of the
first patient in the ZEPHYRUS-2 Phase 3 clinical study of
pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF), a
chronic, progressive, and fatal lung disease.
“Today, treatment for IPF is aimed at relieving symptoms and
slowing disease progression, and disease-modifying treatment
options are urgently needed,” said Elias Kouchakji, M.D., Senior
Vice President, Clinical Development and Drug Safety. “We
are excited to advance the Phase 3 clinical development program for
pamrevlumab, a first-in-class antibody which represents a novel
approach to the treatment of IPF, a disease with survival rates
comparable to those of some of the deadliest cancers.”
ZEPHYRUS-2 is a 52-week randomized, double-blind,
placebo-controlled, multi-center Phase 3 trial designed to evaluate
the efficacy and safety of pamrevlumab in subjects with IPF who
were previously treated with an approved therapy but who
discontinued that therapy.
The primary endpoint of the study is disease progression defined
as a change from baseline in forced vital capacity (FVC) percent
predicted decline ≥10% or death. Secondary endpoints include change
in quantitative lung fibrosis (QLF) and patient-reported outcomes.
Approximately 340 subjects will be enrolled into the global study.
Subjects who complete the 52-week study may be eligible for
rollover into a separate study offering open-label, extension
treatment with pamrevlumab. For more information about ZEPHYRUS-2
please visit www.clinicaltrials.gov (NCT04419558).
“The initiation of our second Phase 3 study of pamrevlumab for
IPF furthers our research on the clinical benefits of inhibiting
connective tissue growth factor (CTGF), an important biological
mediator in fibrotic and proliferative disorders,” said Mark
Eisner, M.D, M.P.H, Chief Medical Officer, FibroGen. “We are
committed to advancing the science of CTGF biology and evaluating
clinical benefit in diverse diseases with unmet medical need,
including IPF, locally advanced unresectable pancreatic cancer and
Duchenne muscular dystrophy.”
The Phase 3 clinical development program for pamrevlumab for IPF
consists of two studies, ZEPHYRUS and ZEPHYRUS-2. ZEPHYRUS is an
ongoing randomized, double-blind, placebo-controlled, multi-center
Phase 3 trial designed to evaluate the efficacy and safety of
pamrevlumab in subjects with IPF over a 52-week period. The primary
endpoint of the study is the change in forced vital capacity (FVC)
from baseline. For more information about ZEPHYRUS please
visit www.clinicaltrials.gov (NCT03955146).
The design of ZEPHYRUS and ZEPHYRUS-2 is supported by safety and
efficacy data from two Phase 2 studies. In a Phase 2, randomized,
double-blind, placebo-controlled trial of pamrevlumab in IPF (Study
067/PRAISE), pamrevlumab demonstrated a statistically significant
difference over placebo in the primary efficacy endpoint of FVC
percent predicted change from baseline to Week 48 (Gorina, ERS
2017). Pamrevlumab achieved superiority over placebo in the
following secondary endpoints: the proportion of subjects with
disease progression (defined as a change from baseline in FVC
percent predicted decline ≥10% or death), time to disease
progression, change from baseline to Week 48 in quantitative lung
fibrosis (QLF) score to Week 48 measured by quantitative HRCT. In
addition, there was a trend towards improvement in patient-reported
quality of life measurements assessed by the SGRQ (positive trends)
and the UCSD-SOBQ, as well as favorable trend in all-cause
mortality.
In a prior single-arm, open-label FGCL-3019-049 study, the
treatment of patients with IPF given 15 mg/kg and 30 mg/kg IV of
pamrevlumab every three weeks was associated with improvement or
stability in quantified scores of whole lung fibrosis in
approximately 35% of subjects at Week 48 (Raghu, 2012). Changes
from baseline in these scores were significantly correlated with
changes in FVC percent predicted value (Raghu, 2012).
About PamrevlumabPamrevlumab is a
first-in-class antibody developed by FibroGen to inhibit the
activity of connective tissue growth factor (CTGF), a common factor
in fibrotic and proliferative disorders characterized by persistent
and excessive scarring that can lead to organ dysfunction and
failure. Pamrevlumab is in Phase 3 clinical development for the
treatment of idiopathic pulmonary fibrosis (IPF) and for the
treatment of locally advanced unresectable pancreatic cancer
(LAPC), and in Phase 2 clinical development for the treatment of
Duchenne muscular dystrophy (DMD). The U.S. Food and Drug
Administration has granted Orphan Drug Designation (ODD) to
pamrevlumab for the treatment of patients with IPF, LAPC, and DMD.
Pamrevlumab has also received Fast Track designation from
the U.S. Food and Drug Administration for the treatment
of patients with IPF and LAPC. Across all clinical studies,
pamrevlumab has consistently demonstrated a good safety and
tolerability profile to date. For information about pamrevlumab
studies currently recruiting patients, please
visit www.clinicaltrials.gov.
About Idiopathic Pulmonary Fibrosis
(IPF)Idiopathic pulmonary fibrosis is a chronic lung
disease characterized by a progressive and irreversible decline in
lung function when lung tissue becomes damaged, stiff, and scarred.
As tissue scarring progresses, transfer of oxygen into the
bloodstream is increasingly impaired, leading to irreversible loss
of lung function, as well as high morbidity and mortality rates.
Average life expectancy is estimated to be three to five years from
diagnosis with approximately two-thirds of patients dying within
five years. Survival rates are comparable to those of some of the
deadliest cancers.
Patients with IPF experience debilitating symptoms, including
shortness of breath and difficulty performing routine functions,
such as walking and talking. Other symptoms include chronic dry,
hacking cough, fatigue, weakness, discomfort in the chest, loss of
appetite, and weight loss. Over the last decade, refinements in
diagnosis criteria and enhancements in high-resolution computed
tomography imaging technology (HRCT) have enabled more reliable
diagnosis of IPF without the need for a lung biopsy.
U.S. prevalence and incidence of IPF is estimated to be 135,000
cases (defined by ICD-9 code) and 21,000 new cases per year,
respectively, based on Raghu et al. (Am J Respir Crit Care Med,
2006) and on data from the United Nations Population Division. We
believe the number of patients will continue to grow due to
heightened awareness and improved methods for detection and
diagnosis.
About FibroGenFibroGen, 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 chronic kidney disease (CKD). Roxadustat
is also in clinical development 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 idiopathic pulmonary
fibrosis (IPF), locally advanced unresectable pancreatic cancer
(LAPC), Duchenne muscular dystrophy (DMD), and coronavirus
(COVID-19). For more information, please
visit www.fibrogen.com.
Forward-Looking StatementsThis 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 September 30, 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.
Investors:Michael Tung, M.D.Corporate Strategy
/ Investor Relations1.415.978.1434mtung@fibrogen.com
Media:Jennifer
Harrington+1.610.574.9196Jennifer.Harrington@gcihealth.com
