FibroGen has concluded the enrolment of patients in the Phase III ZEPHYRUS-2 clinical trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF).
The company has enrolled 372 patients in the ZEPHYRUS-2 trial, which will assess the efficacy and safety of pamrevlumab in patients with IPF.
Pamrevlumab is a potential first in class antibody being developed by the company to restrict connective tissue growth factor (CTGF) activity.
The change from baseline in forced vital capacity (FVC) at 48 weeks is the primary endpoint of the randomised, double-blind, placebo-controlled and multi-centre trial.
FibroGen plans to reveal top line data from the trial in the middle of next year.
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FibroGen chief medical officer Mark Eisner said: “We are pleased to announce the completion of enrollment for our second Phase 3 study of pamrevlumab in IPF.
“The ZEPHYRUS programme consists of two Phase III clinical trials that will evaluate the ability of pamrevlumab to attenuate fibrosis and lung function decline in patients with idiopathic pulmonary fibrosis. IPF is a fatal progressive disease, and patients need new treatment options to improve their clinical outcomes.”
Pamrevlumab is currently in Phase III clinical development to treat locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD), in addition to IPF.
It already received orphan drug designation, and fast track designation from the US Food and Drug Administration to treat IPF, DMD, and LAPC.
In addition, pamrevlumab obtained rare paediatric disease designation from the regulator to treat DMD patients.
According to the company, pamrevlumab showed a safety and tolerability profile that has supported ongoing clinical investigation in IPF, DMD, and LAPC.