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FibroGen Announces Topline Results from Phase 3 ZEPHYRUS-1 Study of Pamrevlumab for the Treatment of Idiopathic Pulmonary Fibrosis - Seite 2
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FibroGen plans to implement a significant cost reduction effort in the U.S. with the intent to extend our cash runway into 2026.
About ZEPHYRUS
A 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.
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About Pamrevlumab
Pamrevlumab 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.