US-based biopharmaceutical firm FibroGen has secured approval from the China Food and Drug Administration (CFDA) to initiate a Phase II/III clinical trial of roxadustat to treat anaemia associated with lower risk myelodysplastic syndromes (MDS).
Roxadustat (FG-4592) is an oral, small molecule, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) being developed to enhance endogenous erythropoietin, iron regulation and minimise hepcidin for promoting erythropoiesis.
The two-part Phase II/III trial will assess the safety and efficacy of roxadustat to treat anaemia in non-transfusion dependent, lower risk MDS patients.
The open-label Phase II part of the trial will enrol up to 40 patients, while the randomised, double-blind, placebo-controlled Phase III part will see an enrolment of 135 subjects.
The product is being developed and commercialised by FibroGen and AstraZeneca in select markets such as China and the US, while FibroGen is responsible for clinical trials and regulatory submissions in the countries and will retain all regulatory licences and manufacturing permits in China.
FibroGen also intends to begin a randomised, double-blind, placebo-controlled Phase III clinical trial in the third quarter of this year to investigate the efficacy and safety of roxadustat in transfusion-dependent lower risk MDS patients with anaemia.
The product is also being evaluated further for the treatment of anaemia associated with chronic kidney disease (CKD).
It has been studied in Phase I and Phase II trials in more than 1,400 CKD patients.
A total of 15 Phase III trials are being planned with an enrolment of 10,000 non-dialysis-dependent and dialysis-dependent CKD patients in the US, Europe, Japan and China.