The commencement triggered a $50m milestone to FibroGen from Astellas under a licensing deal signed between the two companies for the inhibitor of hypoxia-inducible factor prolyl hydroxylase.
FG-4592/ASP1517 demonstrated the potential to maintain hemoglobin levels, without any intravenous iron supplementation, in CKD patients who are not on dialysis and end-stage renal disease patients on dialysis.
FibroGen president and chief executive officer Thomas Neff said the advancement of Phase 3 development of FG-4592/ASP1517 is based on the encouraging results from Phase 2 clinical studies.
"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," Neff added.
Phase 2 clinical studies observed that FG-4592/ASP1517 demonstrated anemia correction in CKD patients, meeting the primary objective.
Astellas Pharma Global Development president Steven Ryder said, "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."