On August 7, 2017 FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, reported financial results for the second quarter of 2017 and announced positive topline results of the company’s Phase 2 randomized, double-blind, placebo-controlled study and two combination sub-studies of pamrevlumab in idiopathic pulmonary fibrosis (IPF) (Press release, FibroGen, AUG 7, 2017, View Source [SID1234520068]). Pamrevlumab is a proprietary anti-connective tissue growth factor (CTGF) antibody being evaluated in fibrotic disease and cancer. Schedule your 30 min Free 1stOncology Demo! "We are very encouraged by the topline IPF Phase 2 clinical study results that we announced today, in which pamrevlumab-treated patients had a significantly lower rate of decline in lung function, as compared to the placebo-treated patients. In addition, pamrevlumab continued to be well tolerated as a monotherapy in this IPF study, and was well tolerated in combination with pirfenidone and nintedanib," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "We believe that the promising outcomes of these studies enable us to advance pamrevlumab into Phase 3 clinical development."
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Recent Developments
Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)
Reported positive topline Phase 2 clinical results from a double-blind, placebo-controlled study, and two double-blind, active-controlled combination sub-studies
Pamrevlumab for Pancreatic Cancer
Orphan Drug Designation status was granted by the U.S. Food and Drug Administration (FDA)
Phase 2 clinical results are expected year-end 2017/first quarter 2018
Roxadustat for Anemia in Chronic Kidney Disease (CKD)
On track to submit the new drug application (NDA) to the FDA in 2018
The independent data safety monitoring board, which reviews the U.S. and European Phase 3 programs quarterly, recommended in August 2017 that all trials continue without modification to current protocols
U.S. Roxadustat for Anemia in Myelodysplastic Syndromes (MDS)
Phase 3 clinical trial is anticipated to start in the third quarter of 2017
China Roxadustat for Anemia in CKD
On track to submit the NDA for anemia associated with CKD in dialysis-dependent and non-dialysis patients to the China Food and Drug Administration in the third quarter of 2017
China Roxadustat for Anemia in MDS
Phase 2/3 clinical study is on schedule to initiate in the fourth quarter of 2017
Corporate and Financial Highlights
Net loss per basic and diluted share for the quarter ended June 30, 2017 was $0.48, as compared to a net income per diluted share of $0.35 a year ago
At June 30, 2017, FibroGen had $414.7 million of cash, restricted time deposits, cash equivalents, investments, and receivables
Closed an equity financing in April 2017 that generated $115.1 million in net proceeds
About Pamrevlumab
Pamrevlumab is a proprietary therapeutic antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in chronic fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. FibroGen is currently conducting clinical studies of pamrevlumab in idiopathic pulmonary fibrosis (IPF), pancreatic cancer, and Duchenne muscular dystrophy (DMD). In desmoplastic or fibrotic cancers, such as pancreatic cancer, CTGF promotes abnormal proliferation of stromal cells and tumor cells. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.
About Roxadustat
Roxadustat is a first-in-class, orally administered small molecule currently in global Phase 3 clinical development as a therapy for anemia associated with chronic kidney disease (CKD). Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that promotes erythropoiesis through increasing endogenous erythropoietin, improving iron regulation, and reducing hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis – increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients – including in the presence of inflammation and without a need for supplemental intravenous iron.
Roxadustat is currently advancing through Phase 3 clinical trials worldwide, supported by extensive Phase 2 clinical data demonstrating correction and maintenance of hemoglobin levels in multiple subpopulations of CKD anemia patients. To date, roxadustat has been evaluated in Phase 1 and Phase 2 studies involving more than 1,400 subjects. Globally, a total of 15 studies are currently underway involving a total of more than 11,000 patients. Of these, 15 are Phase 3 pivotal studies comprising 10,400 patients, and are currently being conducted to support independent regulatory approvals of roxadustat in both non-dialysis and dialysis CKD patients in the U.S., Europe, Japan, and China. Later this year, roxadustat will also enter a Phase 3 clinical trial in the U.S., and a Phase 2/3 trial in China, for the treatment of anemia in myelodysplastic syndromes (MDS). For information about roxadustat studies currently recruiting patients, please visit www.clinicaltrials.gov.