Astellas Enrolls First European Patients In ALPINE Trial
Astellas Pharma Europe Ltd. reported that the first European patients have been enrolled for the global ALPINE trial to evaluate safety and efficacy of roxadustat (ASP1517/FG-4592) as treatment for anemia in patients with chronic kidney disease (CKD). The trial is being conducted in collaboration with Astellas partner FibroGen Inc.
An estimated 1,800 patients will be enrolled in Europe to compare roxadustat to both existing and treatments and placebo. Astellas will conduct three Phase III studies (ALPS, DOLOMITES, PYRENEES) under the ALPINE program covering both non-dialysis and dialysis patients.
Dr. Ashraf Mikhail, senior clinical tutor at Swansea University and Coordinating Investigator for the ALPS study in the UK, said “For years we have had to give people with CKD two injections to treat their anemia. Firstly we give intravenous iron, the building blocks for hemoglobin, and ESA, which processes these building blocks into blood elements. This requires a lot of time, monitoring, testing and patient visits. Roxadustat could allow us to replace all this with one tablet, and potentially transfer management of this condition from secondary to primary care.”
Chronic kidney disease affects approximately more than 10% of people in Europe, according to the European Kidney Health Alliance. Around 12% of CKD patients also have anemia. The disease is a growing public health issue not only in Europe but also around the world.
Roxadustat is the first compound in a potential novel therapeutic class called as hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitors (or HIF-PHIs) to advance into Phase 3 studies. The drug elevates Hb levels through a mechanism that mimics natural effects of high altitude. It is known that HB production increases at high altitude and HIF levels promotes generation of the red blood cells which carry Hb. The drug utilizes the body’s own stores of iron to increase HIF and Hb levels to fight against anemia.
Dr. Michael Allen, therapeutic area head of Urology and Nephrology at Astellas Pharma Global Development, said “Roxadustat has the potential to change the treatment of anemia associated with CKD. We are very pleased to mark this milestone in roxadustat's development, which is also an important one for Astellas.”
The company has licensed several rights to roxadustat from FibroGen in certain countries including the Middle East, Japan, and South Africa among others. Astellas said it will file for regulatory approval to the EMA in the future.