FibroGen, Inc. ("FibroGen"), and Astellas Pharma Inc. (Tokyo:4503, "Astellas"), announced today the initiation of the first clinical study in the Phase 3 clinical development program of FG-4592/ASP1517, an orally administered small molecule, for treatment of anemia associated with chronic kidney disease ("CKD") in patients not on dialysis and on dialysis, to support approval in the U.S. and Europe. FG-4592/ASP1517 is an inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (a "HIF-PHI"), belonging to a new class of anemia therapeutic agents.
The decision to initiate the Phase 3 program in the U.S. and Europe is based on the completion of Phase 2 clinical studies showing that FG-4592/ASP1517 met its primary objective of demonstrating anemia correction in treatment-naïve CKD patients not on dialysis as well as maintenance of hemoglobin in CKD patients on dialysis and not on dialysis. Results relating to Phase 2 clinical development of FG-4592/ASP1517 were most recently presented at the American Society of Nephrology Kidney Week 2012, in San Diego, California.
"Based on the encouraging results from FG-4592/ASP1517 Phase 2 clinical studies, we are pleased to advance to Phase 3 development of FG-4592/ASP1517," said Thomas B. Neff, President and Chief Executive Officer of FibroGen. "FG-4592/ASP1517 has the potential to offer CKD patients a more convenient oral therapy for anemia, one that is effective without intravenous (IV) iron supplementation, and that provides the additional benefits of cholesterol reduction and reduction in hypertension, which may have importance relative to the current standard of care in CKD management."