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news.FibroGen, a biotechnology-based drug discovery company, has resumed patient recruitment in a Phase II study of FG-4592/ASP1517, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor in development for the treatment of anemia associated with chronic kidney disease.
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The Phase II study is a single-blind, placebo-controlled, dose-escalation trial expected to enroll a total of 130 patients with anemia of chronic kidney disease (CKD) who are not receiving dialysis. The objectives of the study are to characterize safety, pharmacokinetics and pharmacodynamics, of FG-4592/ASP1517 and to obtain exploratory efficacy data.
Frank Valone, chief medical officer of FibroGen, said: “Anemia of CKD is under-recognized and undertreated despite the severity of associated risks including increased rate of progression to end-stage renal disease, cardiovascular complications and death.
“Treatment of anemia using orally bioavailable hypoxia-inducible factor-prolyl hydroxylase inhibitors represents a promising investigational therapeutic approach with the potential to meet a large unmet need for anemia therapy in the nondialysis patient population.”