FibroGen, Inc. (NASDAQ: FGEN) today announced the initiation of an
open-label, randomized, parallel-arm study investigating the
efficacy and safety of pamrevlumab versus standard of care in
patients with severe coronavirus 2019 (COVID-19) infection. The
trial is being conducted by Professor Luca Richeldi, M.D., Ph.D.,
Head of the Division of Pulmonary Medicine at Fondazione
Policlinico Universitario A. Gemelli IRCCS, and Professor of
Respiratory Medicine at Catholic University of the Sacred Heart in
Rome, Italy.
BOREA is a Phase 2/3 investigator-initiated
clinical trial investigating the efficacy and safety of pamrevlumab
in approximately 68 patients hospitalized with COVID-19. The
primary objective of this study is to assess the effect of
pamrevlumab on blood oxygenation in patients with COVID-19
infection. Patients will be randomized to treatment with
pamrevlumab or standard of care in a 1:1 ratio. Based on the
investigator’s decision, a subgroup of patients may continue
treatment for up to 12 weeks.
“Recent data indicate the presence of interstitial
pneumonia in the majority of hospitalized patients infected with
COVID-19. The interstitial pneumonia is usually bilateral and leads
to decreased blood oxygen levels, respiratory failure, intubation,
and, ultimately, death in a significant proportion of patients who
require mechanical ventilation,” said Elias Kouchakji, M.D., Senior
Vice President, Clinical Development, Drug Safety, and
Pharmacovigilance, FibroGen. “Connective tissue growth factor
(CTGF) may promote vascular leakage and lead to pulmonary edema.
Administration of pamrevlumab, an anti-CTGF monoclonal antibody,
may reverse this edema, and thus improve oxygenation in patients
with COVID-19-induced pneumonia.”
Pamrevlumab is a first-in-class antibody developed
by FibroGen to inhibit the activity of CTGF, a common factor in
fibrotic and proliferative disorders characterized by persistent
and excessive scarring that can lead to organ dysfunction and
failure. This trial will assess pamrevlumab’s effect on patient
time to and on ventilatory support, currently the most urgent need,
and its potential to reduce mortality and fibrotic sequelae in the
lung.
FibroGen today also announced the planned
initiation of two additional randomized, double-blind,
placebo-controlled Phase 2 studies investigating the efficacy and
safety of pamrevlumab versus standard of care in patients with
severe COVID-19 infection in the United States.
- The Investigational New Drug (IND) application for the first
trial has been approved by the U.S. Food and Drug Administration
(FDA), and it will assess the efficacy and safety of pamrevlumab in
approximately 130 patients hospitalized with COVID-19 in the acute
setting.
° This is a randomized,
double-blind, placebo-controlled study, to assess the efficacy and
safety of pamrevlumab in hospitalized patients with acute COVID-19
infection, in a 1:1 ratio.° The primary efficacy assessment is
the proportion of hospitalized COVID-19 patients who never receive
mechanical ventilation and/or extracorporeal membrane oxygenation
(ECMO) and remain alive at day 28.
- The second planned U.S. trial, under discussion with the FDA,
is expected to assess the longer term efficacy and safety of
pamrevlumab in patients who recovered or are recovering from
COVID-19 infection with evidence of interstitial lung disease.
“Given our expertise in CTGF biology and its
potential application in lung disease, we have a unique approach to
the treatment of patients suffering from severe pulmonary
involvement of COVID-19. The Italy and U.S. trials will determine
if pamrevlumab treatment of hospitalized COVID-19 patients improves
patient outcomes, both during the acute phase of infection and
longer term with improved outcomes in interstitial lung disease,”
said Enrique Conterno, Chief Executive Officer, FibroGen. “In these
devastating times, we are grateful for the collaboration of health
authorities, health care providers, and patients in enabling the
conduct of these trials.”
About PamrevlumabPamrevlumab is a
first-in-class antibody developed by FibroGen that inhibits the
activity of connective tissue growth factor (CTGF), a common factor
in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3
clinical development for the treatment of idiopathic pulmonary
fibrosis (IPF) and locally advanced unresectable pancreatic cancer
(LAPC), and in Phase 2 clinical development for the treatment of
Duchenne muscular dystrophy (DMD) and coronavirus (COVID-19). For
information about pamrevlumab studies currently recruiting
patients, please visit www.clinicaltrials.gov.
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 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, 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 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.
Contact:FibroGen, Inc.
Media Inquiries:Sara
Iacovino1.703.474.4452sara.iacovino@gcihealth.com
Investors:Michael Tung, M.D.Corporate Strategy /
Investor Relations 1.415.978.1434mtung@fibrogen.com
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