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."
Steven Ryder MD, FACP, President of Astellas Pharma Global Development Inc., stated, "The initiation of Phase 3 clinical development of FG-4592/ASP1517 reaffirms our commitment to the treatment of kidney disease. Through this new mechanism of action, we hope to provide significant therapeutic benefits to patients with anemia associated with chronic kidney disease."
Astellas has licensed from FibroGen certain rights to FG-4592/ASP1517 (Astellas designation ASP1517) in Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. As part of these agreements, FibroGen and Astellas equally share development costs for FG-4592/ASP1517 in the U.S. and Europe, and Astellas makes milestone payments for its clinical advancement and approvals in Europe and in Japan, as well as other subsequent events. In Japan, Phase 1 studies have been completed and a Phase 2 program is expected to start in early 2013. FibroGen retains the rights to its anemia therapies in North America and South America, remaining parts of Africa, and all of Asia Pacific ex-Japan. FibroGen is also developing FG-4592 for the treatment of CKD anemia in the People's Republic of China, where Phase 2 studies have been completed.
FibroGen has received a $50 million milestone from Astellas for the initiation of the Phase 3 program.