FG-3019: Phase II expanded

FibroGen expanded an open-label Phase II trial evaluating 15 mg/kg IV FG-3019 given every 3 weeks for 45 weeks to add a second arm of 30 patients to receive 30 mg/kg FG-3019. Patients who received the initial 15 mg/kg dose who appear stable or have improved FVC will also have the option to continue on the study for an additional year. The company said it decided to expand the trial after preliminary data from the lower dose, as well as data from other trials, showed that higher doses of FG-3019 are associated with "a more robust biological and clinical response." The trial has enrolled 54 patients to receive low-dose FG-3019. FibroGen said FG-3019 was well tolerated in all clinical studies. ...