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FibroGen (FGEN) Presents Data from its PRAISE Phase 2b Study of Pamrevlumab in Idiopathic Pulmonary Fibrosis

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Clinical Data
Quantitative lung fibrosis (QLF) measurements appear to be an objective method for quantifying the change in lung fibrosis captured by HRCT (a non-invasive imaging tool). In PRAISE, the change in QLF volumes in pamrevlumab-treated patients over 48 weeks was significantly less than in patients on placebo, and the treatment difference between pamrevlumab vs placebo was observed as early as six months. The change from baseline in QLF volume for pamrevlumab-treated patients was 24.8 ml vs 86.4 ml for placebo at Week 24, with a treatment difference of -61.6 ml, p=0.0090. The change in QLF volume from baseline to 48 weeks was 75.4 ml in pamrevlumab-treated patients vs 151.5 ml from baseline to 48 weeks in patients on placebo, with a treatment difference of -76.2 ml, p=0.038. These QLF results on pamrevlumab’s reduction of fibrotic build up in the lungs of IPF patients correlate with attenuation of the rate of decline in FVC % predicted, the primary endpoint of this study, with Spearman’s correlation coefficient of -0.64, p=0.0001.
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Catalyst Date
Occurred on:
May 21, 2018
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Related Keywords Praise, Pamrevlumab And Fibrosis