San Francisco, USA-headquartered FibroGen (Nasdaq: FGEN) and its subsidiary FibroGen China today reported positive top-line results from two Phase III clinical studies of the company’s anemia candidate roxadustat (FG-4592).
Roxadustat is a first-in-class, orally-administered small molecule for the treatment of anemia in patients with chronic kidney disease.
Both of the Phase III studies met their primary efficacy endpoints in the 26 week trial, in which 151 anemia patients were enrolled, achieving a statistically-significant increase in hemoglobin levels.
A 52-week safety assessment involving over 100 patients is reported by the company to be ongoing, with results expected in June 2017.
The company is collaborating with AstraZeneca (LSE: AZN) over the development and commercialization of roxadustat in China, the USA, and other markets.
Under the terms of the agreement, FibroGen will conduct all clinical trials in connection with the drug in China, and will hold all eventual regulatory licenses and permits that may be issued by Chinese regulators.
Once marketing approval has been achieved, FibroGen China will manage manufacturing and medical affairs and AstraZeneca will manage launch and commercialization activities in China.
Tom Neff, chief executive of FibroGen, said: “We are very encouraged by the top-line results of these two pivotal Phase III studies for roxadustat, which bring us closer to the first oral anemia therapy that does not require injectable administration or IV iron supplementation.”
“In addition, use of roxadustat is free of the burden of cold-chain storage and maintaining sterility, and costly distribution infrastructure. Data from these two studies will be used to complete our new drug application submission in China later this year.”