FibroGen, Inc. (NASDAQ:FGEN), announced on 5/21/18 that updated results from the company’s randomized, double-blind, placebo-controlled Phase 2b PRAISE study of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF) were presented in several poster presentations at the American Thoracic Society (ATS) 2018 in San Diego, California. In total, the company is presenting four abstracts on pamrevlumab.
Pamrevlumab, a proprietary first-in-class antibody targeting connective tissue growth factor (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 (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 (qHRCT). The pamrevlumab findings are consistent with reported results from a prior Phase 2 study in IPF.
“We are excited to present additional analyses of the PRAISE Phase 2b trial that confirm and expand our understanding of positive safety and efficacy results with pamrevlumab, with statistically significant treatment effects in slowing IPF progression with encouraging results in both lung function (FVC) and in lung fibrosis (QLF) for the first time in a controlled study,” said Elias Kouchakji, M.D., Senior Vice President, Clinical Development and Drug Safety. “This study demonstrates the therapeutic potential of pamrevlumab and, brings us one step closer to helping IPF patients.”
Pamrevlumab recently received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with locally advanced unresectable pancreatic cancer. Evaluated in multiple Phase 2 clinical studies, pamrevlumab has also demonstrated a good safety and tolerability profile.
Pamrevlumab is a first-in-class antibody 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 advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), for which FibroGen was granted Orphan Drug Designation (ODD).
It is also in phase 2 trials for Duchenne muscular dystrophy (DMD).