Astellas Pharma and FibroGen have started a Phase II study of ASP1517/FG-4592 to treat anaemia of chronic kidney disease (CKD) in patients on dialysis in Japan.
ASP1517/FG-4592 is the orally administered small molecule inhibitor of hypoxia-inducible factor prolyl hydroxylase (HIF-PHI).
The candidate has been shown to correct and maintain haemoglobin levels without the need for supplementation with intravenous iron in CKD patients not yet receiving dialysis and in end-stage renal disease patients receiving dialysis.
In late-2013, Astellas expects to conduct an additional Phase II study in Japan of ASP1517/FG-4592 in non-dialysis patients.
The first clinical study in Phase III development of ASP1517/FG-4592 began in December 2012 to support approval in the US and Europe.
The beginning of Phase II study triggered a $12.5m milestone payment from Astellas, which is responsible for the development cost of ASP1517/FG-4592 in Japan as part of the terms and conditions of an exclusive license agreement with FibroGen.
According to the terms of the deal signed between the parties, FibroGen and Astellas equally share development costs for ASP1517/FG-4592 in the US and in Europe.
In addition to other subsequent events, FibroGen is eligible for milestone payments upon clinical advancement and approvals in Europe and Japan.
FibroGen, which completed Phase II studies of ASP1517/FG-4592 to treat CKD anaemia in the People’s Republic of China, retained rights to its anaemia therapies in North America and South America, remaining parts of Africa and all of Asia Pacific outside of Japan.