FibroGen Announces First Patient Enrolled in Pamrevlumab Clinical Trial in Patients Hospitalized in U.S. with Acute COVID-19
June 23 2020 - 7:00AM
FibroGen, Inc. (NASDAQ: FGEN) today announced the initiation of a
randomized, double-blind, placebo-controlled Phase 2 Study
investigating the efficacy and safety of pamrevlumab in
hospitalized patients with acute coronavirus 2019 (COVID-19)
infection. This multicenter trial is being conducted in the U.S.
and will enroll approximately 130 patients 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, and patients will be randomized to treatment with
pamrevlumab or standard of care in a 1:1 ratio. The primary
efficacy assessment is the proportion of hospitalized COVID-19
patients who have not received mechanical ventilation and/or
extracorporeal membrane oxygenation (ECMO) and remain alive at Day
28.
“The majority of patients with severe forms of COVID-19 have
bilateral interstitial pneumonia, causing reduction in oxygenation
and severe respiratory failure,” said Elias Kouchakji, M.D., Senior
Vice President, Clinical Development, Drug Safety, and
Pharmacovigilance, FibroGen. “The administration of pamrevlumab, a
first-in-class anti-connective growth factor monoclonal antibody,
could protect the lung from the immediate consequences of the
infection presented as acute respiratory distress syndrome.”
A second planned U.S. trial is expected to assess the longer
term efficacy and safety of pamrevlumab in patients who have
recovered or are recovering from COVID-19 infection with evidence
of interstitial lung disease.
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.
“Given our expertise in CTGF biology and the potential
application of this unique approach to the treatment of patients
with acute COVID-19 infection, we are excited to begin enrolling
this trial in the U.S.” said Enrique Conterno, Chief Executive
Officer, FibroGen. “We are grateful for the collaboration of the
FDA, investigators, and patients in enabling the conduct of this
trial.”
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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