FibroGen Announces First Patient Enrolled in Pamrevlumab Phase 3 Clinical Trial in Patients with Duchenne Muscular Dystrophy
August 11 2020 - 7:00AM
FibroGen, Inc. (NASDAQ: FGEN) announced the initiation of LELANTOS,
a Phase 3, randomized, double-blind, placebo-controlled trial of
pamrevlumab or placebo in combination with systemic
corticosteroids in patients with non-ambulatory Duchenne muscular
dystrophy (DMD).
The primary objective of this global study is to evaluate the
effect of pamrevlumab on muscle function in patients with DMD.
Approximately 90 patients will be randomized 1:1 to receive
pamrevlumab plus systemic corticosteroids, or placebo plus systemic
corticosteroids, for up to 52 weeks. The primary efficacy
endpoint is the change in the total score of performance of upper
limb (PUL) assessment, from baseline to Week 52, and additional
endpoints include pulmonary and cardiac function tests. Subjects
who complete the 52-week study will be eligible for rollover into
an open-label extension study with pamrevlumab and systemic
corticosteroids.
“Duchenne muscular dystrophy is a progressive disease associated
with muscle deterioration and weakness, often leading to patients
becoming wheelchair-bound by the age of 12,” said Elias Kouchakji,
M.D., Senior Vice President, Clinical Development, Drug Safety, and
Pharmacovigilance, FibroGen. “In DMD, inhibition of connective
tissue growth factor (CTGF) by pamrevlumab could result in
decreased fibrosis in muscles leading to increased muscle function.
We hope pamrevlumab provides a meaningful treatment for the
patients with this debilitating 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.
Importantly, skeletal muscle from DMD patients shows elevated
levels of CTGF, and a major manifestation of DMD is cardiac
fibrosis.
“Initiation of the LELANTOS Phase 3 clinical trial represents a
key milestone for FibroGen and for our DMD clinical program, as
well as an important development for the patients and families
affected by Duchenne,” said Enrique Conterno, Chief Executive
Officer, FibroGen. “We are grateful for the collaboration of global
regulators, investigators, caregivers, 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), locally advanced unresectable pancreatic cancer
(LAPC), and Duchenne muscular dystrophy (DMD); and in Phase 2
clinical development for coronavirus (COVID-19). For information
about pamrevlumab studies currently recruiting patients, please
visit www.clinicaltrials.gov.
About Duchenne Muscular DystrophyDuchenne
muscular dystrophy is a rare and debilitating neuromuscular disease
that affects approximately 1 in every 3,500 newborn boys. The fatal
disease is caused by a genetic mutation leading to the absence or
defect of dystrophin, a protein necessary for normal muscle
function. The absence of dystrophin results in muscle weakness,
muscle loss, fibrosis, and inflammation. Patients with DMD are
often wheelchair-bound before the age of 12, and their progressive
muscle weakness may lead to serious medical problems relating to
respiratory and cardiac muscle.
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 (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
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and contentions and are not historical facts and typically are
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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 1.415.630.0131mtung@fibrogen.com
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