FibroGen's pamrevlumab meets in Phase II for IPF

FibroGen Inc. (NASDAQ:FGEN) reported top-line data from a Phase II trial in 103 patients with idiopathic pulmonary fibrosis (IPF) showing that pamrevlumab (FG-3019) as monotherapy met the primary endpoint of improving forced vital capacity (FVC) percent predicted from baseline to week 48 vs. placebo. Specifically, pamrevlumab led to a lower mean decline on the endpoint vs. placebo (2.85% vs. 7.17%, p=0.0331). Additionally, patients treated with pamrevlumab had a mean decrease in FVC of 129 mL from baseline to week 48 vs. 308 mL for placebo (p=0.0249). Patients received 30 mg/kg IV pamrevlumab every 3 weeks for a total of 16 total infusions.

In 57 patients enrolled in the double-blind, placebo- and active-controlled substudies of the trial, pamrevlumab plus IPF drugs Esbriet pirfenidone from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) and Ofev nintedanib from Boehringer Ingelheim GmbH (Ingelheim, Germany) were well tolerated...