FibroGen, Inc. (NASDAQ: FGEN) today announced topline results from
its Phase 3 ZEPHYRUS-1 trial evaluating the safety and efficacy of
pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF).
The study compared treatment with pamrevlumab to placebo and did
not meet the primary endpoint of change from baseline in forced
vital capacity (FVC) at week 48 (p=0.29). The mean decline in FVC
from baseline to week 48 was 260 ml in the pamrevlumab arm compared
to 330 ml in the placebo arm (placebo-corrected difference of 70
ml; 95% CI -60 to 190 ml). The secondary endpoint of time to
disease progression (FVC percent predicted decline of ≥10% or
death) was also not met (HR= 0.78; 95% CI 0.52 to 1.15).
In the safety analysis, pamrevlumab was generally safe and well
tolerated and the majority of treatment emergent adverse events
were mild or moderate. Treatment-emergent serious adverse events
were observed in 28.2% of patients in the pamrevlumab group and
34.3% of patients in the placebo group.
Based on the results of ZEPHYRUS-1, ZEPHYRUS-2, the second Phase
3 clinical trial, will be discontinued. FibroGen plans to
communicate the results of the ZEPHYRUS-1 study at an upcoming
medical forum.
“We are deeply disappointed that these results do not support
pamrevlumab as a new treatment for IPF,” said Mark D. Eisner, MD,
MPH, Chief Medical Officer, FibroGen. “FibroGen would like to thank
the patients and clinical trial investigators for their dedication
to participating in this study.”
FibroGen anticipates reporting topline data from Phase 3 studies
with pamrevlumab for the treatment of ambulatory DMD patients
(LELANTOS-2) in 3Q 2023, locally advanced pancreatic cancer (LAPIS)
in 1H 2024, and metastatic pancreatic cancer (Precision
Promise).
“FibroGen’s focus will be on reporting the additional
pamrevlumab studies, advancing our pipeline, and continuing
commercialization of roxadustat in China and in countries where
approved,” said Enrique Conterno, Chief Executive Officer,
FibroGen.
Upcoming Milestones:
- Topline data from the LELANTOS-2 Phase 3 study of pamrevlumab
in ambulatory DMD patients expected 3Q 2023.
- Topline data from the LAPIS Phase 3 study of pamrevlumab in
locally advanced unresectable pancreatic cancer (LAPC) expected 1H
2024.
- Topline data from the Pancreatic Cancer Action
Network (PanCAN) Precision PromiseSM Phase 3 study of
pamrevlumab in metastatic pancreatic cancer.
- Anticipate the filing of up to two INDs: FG-3165 (anti-Gal9
antibody) 1Q 2024 and FG-3163 (anti-CCR8 antibody) 4Q 2023.
- Anticipate the initiation of a Phase 2 trial of FG-3246, a
first-in-class antibody-drug conjugate (ADC) targeting a novel
epitope on CD46 for metastatic castration-resistant prostate cancer
(mCRPC) in 2H 2024.
Cash Runway:FibroGen plans to implement a
significant cost reduction effort in the U.S. with the intent to
extend our cash runway into 2026.
About ZEPHYRUSA total of 356 patients with IPF
were enrolled into ZEPHYRUS-1, a randomized, double-blind,
placebo-controlled, multi-center Phase 3 trial designed to evaluate
the efficacy and safety of pamrevlumab in patients with IPF.
Patients were randomized (1:1) to receive either pamrevlumab or
placebo for 48 weeks.
The Phase 3 clinical development program evaluating pamrevlumab
for the treatment of IPF consists of two studies, ZEPHYRUS-1 and
ZEPHYRUS-2. These trials are randomized, double-blind,
placebo-controlled, multi-center Phase 3 trials designed to
evaluate the efficacy and safety of pamrevlumab in patients with
IPF. For more information about ZEPHYRUS-1 and ZEPHYRUS-2, please
visit www.clinicaltrials.gov (NCT03955146 and
NCT04419558).
About Idiopathic Pulmonary Fibrosis
(IPF)Idiopathic pulmonary fibrosis is a chronic lung
disease characterized by a progressive and irreversible decline in
lung function in which 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.
About PamrevlumabPamrevlumab is a potential
first-in-class antibody being 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 locally advanced unresectable pancreatic cancer
(LAPC), and ambulatory Duchenne muscular dystrophy (DMD), and in
Phase 2/3 for the treatment of metastatic pancreatic cancer. The
U.S. Food and Drug Administration has granted Orphan Drug
Designation, and Fast Track designation to pamrevlumab for the
treatment of patients with DMD, and LAPC. The U.S. Food and Drug
Administration has also granted Rare Pediatric Disease Designation
to pamrevlumab for the treatment of patients with DMD. Pamrevlumab
has demonstrated a safety and tolerability profile that has
supported ongoing clinical investigation in IPF, DMD, and LAPC.
Pamrevlumab is an investigational drug and not approved for
marketing by any regulatory authority. For information about our
pamrevlumab studies 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 connective tissue
growth factor (CTGF) biology and hypoxia-inducible factor (HIF) to
advance innovative medicines for the treatment of unmet needs.
Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical
development for the treatment of locally advanced unresectable
pancreatic cancer (LAPC), metastatic pancreatic cancer, and
ambulatory Duchenne muscular dystrophy (DMD). Roxadustat (爱瑞卓®,
EVRENZOTM) is currently approved in China, Europe, Japan, and
numerous other countries for the treatment of anemia in CKD
patients on dialysis and not on dialysis. Roxadustat is in clinical
development for chemotherapy-induced anemia (CIA) in China.
FibroGen recently expanded its research and development portfolio
to include product candidates in the immuno-oncology space along
with an exclusive license for FOR46. For more information, please
visit www.fibrogen.com.
Forward-Looking Statements This release
contains forward-looking statements regarding FibroGen’s strategy,
future plans and prospects, and the development and
commercialization of the company’s product candidates. These
forward-looking statements include, but are not limited to,
statements about FibroGen’s plans and objectives 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.
FibroGen’s 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 its
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, 2022 and our Quarterly Report on Form 10-Q for
the quarter ended March 31, 2023, each as 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 FibroGen undertakes no obligation to update
any forward-looking statement in this press release, except as
required by law.
Contacts:FibroGen, Inc.
Investors:Meichiel KeenanInvestor Relations and
Corporate Communicationsmkeenan@fibrogen.com
Media:Michael Szumeramszumera@fibrogen.com
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