On November 8, 2016 FibroGen, Inc. (NASDAQ:FGEN), a research-based biopharmaceutical company, reported financial results for the quarter ended September 30, 2016 and provided an update on the company’s recent developments (Press release, FibroGen, NOV 8, 2016, View Source;p=RssLanding&cat=news&id=2220698 [SID1234516521]).
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"The completion of enrollment in our Phase 3 roxadustat studies in China is a significant milestone for FibroGen and our first-in-class small molecule treatment for anemia. We are gratified to be able to advance this promising new therapeutic for patients with chronic kidney disease," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "In collaboration with our world-class partners, AstraZeneca and Astellas, we have substantially expanded the reach of our global development programs, while efficiently managing use of our resources."
Recent Developments
Roxadustat (FG-4592)
Anemia in Chronic Kidney Disease (CKD):
Completed enrollment of Phase 3 clinical development program in China for treatment of anemia in dialysis and non-dialysis chronic kidney disease patients
Initiating new drug application process in China in 2016, and expect to announce topline Phase 3 data in early 2017
In August, the independent data safety monitoring board reviewing the China Phase 3 data recommended that these studies continue without modification to current protocols
In October, the independent data safety monitoring board reviewing Phase 3 studies to support U.S. and European regulatory submissions recommended these studies continue without modification to current protocols
Achieved initial target enrollment objectives for all three FibroGen-sponsored Phase 3 clinical trials supporting U.S. and European approval, and are continuing to enroll Global Phase 3 program focused on U.S. incident dialysis and non-dialysis patients
Results from the Japan Phase 2 study in CKD non-dialysis-dependent patients will be presented at the American Society of Nephrology’s Kidney Week in November 2016
Remain on track for an NDA submission for roxadustat in the United States in 2018
Other Anemia Program Highlights
The U.S. FDA accepted the company’s investigational new drug application for a Phase 3 trial evaluating roxadustat for the treatment of anemia in myelodysplastic syndrome (MDS) patients
Pamrevlumab (FG-3019)
Fibrosis and Other Fibroproliferative Diseases
Data presented from the open-label extension of the 049 study in idiopathic pulmonary fibrosis (IPF) at the 19th International Colloquium on Lung and Airway Fibrosis in September showed no safety issues during prolonged treatment with pamrevlumab
Trends toward improved or stable pulmonary function and stable fibrosis observed in the initial one-year study (049) have continued among patients participating in the extension study
Anticipate topline results for 067 IPF placebo-controlled study and combination therapy sub-study in summer 2017
Continue to enroll locally advanced pancreatic cancer patients in open-label, randomized Phase 2 trial
Expect to present updated, interim results from open-label, randomized Phase 2 pancreatic cancer study in January 2017
Continue to enroll in the company’s open-label study of pamrevlumab in non-ambulatory Duchenne muscular dystrophy patients
Financial Highlights
Net loss per basic and diluted share for the quarter ended September 30, 2016, was $0.38, as compared to $0.74 a year ago.
At September 30, 2016, FibroGen had $356.8 million of cash, cash equivalents, investments, receivables, and restricted cash.