FibroGen announces updated results from PRAISE study at ATS
FibroGen announced that updated results from the company's randomized, double-blind, placebo-controlled Phase 2b PRAISE study of pamrevlumab in patients with idiopathic pulmonary fibrosis, or IPF, were presented in several poster presentations at the American Thoracic Society, or ATS 2018. In total, the company is presenting four abstracts on pamrevlumab. Pamrevlumab, a proprietary first-in-class antibody targeting connective tissue growth factor, or CTGF, currently being developed for the treatment of fibrotic and fibroproliferative disorders, has demonstrated favorable results in slowing disease progression as measured by forced vital capacity, or FVC in IPF patients in two Phase 2 trials. The poster presentation at ATS presents additional results demonstrating that pamrevlumab treatment achieved a statistically significant reduced rate of progression of lung fibrosis compared to placebo using quantitative high resolution computed tomography, or HRCT. The pamrevlumab findings are consistent with reported results from a prior Phase 2 study in IPF. Quantitative lung fibrosis, or QLF measurements appear to be an objective method for quantifying the change in lung fibrosis captured by HRCT. 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. 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. 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. The PRAISE Phase 2b study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of pamrevlumab in patients with mild-to-moderate IPF. One hundred and three patients were randomized to receive either 30 mg/kg of pamrevlumab or placebo intravenously every three weeks. Lung function assessments were conducted at baseline and at Weeks 12, 24, 36, and 48. Quantitative HRCT assessments were performed at baseline and at Weeks 24 and 48. Additional secondary endpoints of the study were disease progression, health-related quality of life, and safety.