FibroGen and Astellas Pharma have announced the initiation of a Phase III programme assessing FG-4592/ASP1517 for the treatment of anaemia in chronic kidney disease (CKD) patients either on or not on dialysis.
The results obtained from the Phase III clinical development programme are expected to support the regulatory approval of FG-4592/ASP1517, an inhibitor of hypoxia-inducible factor prolyl hydroxylase, in the US and Europe.
FibroGen president and CEO Thomas Neff said the encouraging results from FG-4592/ASP1517 Phase II clinical studies form the basis to advance to Phase III development of FG-4592/ASP1517.
"FG-4592/ASP1517 has the potential to offer CKD patients a more convenient oral therapy for anaemia, 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 said.
During Phase II studies, FG-4592/ASP1517 had demonstrated anaemia correction in treatment-naïve CKD patients not on dialysis, while maintaining haemoglobin in CKD patients either on or not on dialysis.
Astellas Pharma Global Development president Dr Steven Ryder said; "The initiation of Phase III clinical development of FG-4592/ASP1517 reaffirms our commitment to the treatment of kidney disease."
Under the licensing agreement signed between both the companies, FibroGen earned a $50m milestone from Astellas for the commencement of the Phase III programme.