FibroGen announces first patient dosed in ZEPHYRUS, a phase III clinical trial of pamrevlumab for idiopathic pulmonary fibrosis.
FibroGen, Inc. announced dosing of the first patient in the ZEPHYRUS Phase III clinical study of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF)."There is an urgent need for new treatments that will help IPF patients, who have limited or no treatment options,� said Luca Richeldi, M.D., Ph.D., Head of the Division of Pulmonary Medicine at Agostino Gemelli University Hospital of the Catholic University of the Sacred Heart in Rome, Italy. �Pamrevlumab has demonstrated positive efficacy and safety results with statistically significant treatment effects in slowing IPF progression as well as promising findings in improving lung function and lung fibrosis in prior studies. It is exciting to see pamrevlumab, as a potential new therapy, begin the ZEPHYRUS Phase III study.�
ZEPHYRUS is a randomized, double-blind, placebo-controlled, multi-center Phase III trial designed to evaluate the efficacy and safety of pamrevlumab in subjects with IPF over a 52-week period. Approximately 565 subjects will be enrolled into the global study. The primary endpoint of the study is the change in forced vital capacity (FVC) from baseline. Subjects who complete the 52-week study may be eligible for rollover into a separate study offering open-label, extension treatment with pamrevlumab. The design of ZEPHYRUS is supported by safety and efficacy data from two Phase II studies. In a Phase II, randomized, double-blind, placebo-controlled trial of pamrevlumab in IPF (Study 067/PRAISE), pamrevlumab demonstrated a statistically significant difference over placebo in the primary efficacy endpoint of FVC percent predicted change from baseline to Week 48 (Gorina, ERS 2017). Pamrevlumab achieved superiority over placebo in the following secondary endpoints: the proportion of subjects with disease progression (defined as a change from baseline in FVC percent predicted decline ?10% or death), time to disease progression, change from baseline to Week 48 in quantitative lung fibrosis (QLF) score to Week 48 measured by quantitative HRCT. In addition, there was a trend towards improvement in patient-reported quality of life measurements assessed by the SGRQ (positive trends) and the UCSD-SOBQ, as well as favorable trend in all-cause mortality.
In a prior single-arm, open-label FGCL-3019-049 study, the treatment of patients with IPF given 15 mg/kg and 30 mg/kg IV of pamrevlumab every three weeks was associated with improvement or stability in quantified scores of whole lung fibrosis in approximately 35% of subjects at Week 48 (Raghu, 2012). Changes from baseline in these scores were significantly correlated with changes in FVC percent predicted value (Raghu, 2012).