Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, which is under phase 3 development by GSK to treat anemia associated with chronic kidney disease (CKD).
Inhibition of oxygen-sensing prolyl hydroxylase enzymes will help stabilize hypoxia-inducible factors, enabling to transcript erythropoietin and other genes engaged in the production of red blood cells and iron metabolism.
Kyowa Hakko Kirin corporate strategy and planning department director and executive officer Wataru Murata said: “With this collaboration, we look to expand our existing product portfolio in Nephrology and meet medical needs by providing more treatment options for patients suffering with anaemia associated with CKD.”
As per terms of the deal, GSK will take responsibility to complete the ongoing phase 3 clinical program and regulatory submissions for marketing authorization in Japan.
Kyowa Hakko Kirin will exclusively distribute daprodustat in the Japanese market. Both firms will involve in launch activities, including engagement of healthcare professionals and commercial activities.
GSK has an ongoing global phase 3 registration program in addition to the Japanese development program.
Ascend-D has been designed to recruit around 3,000 dialysis dependent patients with anemia associated with CKD switching from an erythropoietin-stimulating agent. The firm completed recruitment and planning to reveal results in 2020.
Ascend-ND has been designed to enroll around 4,500 non-dialysis dependent patients with anaemia associated with CKD. It will include patients either switching from or naive to an ESA.
The recruitment of patients is underway, and the results are expected in 2020.
GSK R&D president and chief scientific officer Dr Hal Barron said: “We anticipate making a regulatory submission to the Japanese Ministry of Health, Labour and Welfare in 2019 and if approved, we believe daprodustat would be an important new oral treatment option for Japanese patients with anaemia associated with CKD.”
“We look forward to working with Kyowa Hakko Kirin, given their extensive experience in this area, to successfully launch and commercialise daprodustat in Japan.”