Alexion Launches Eculizumab Trial In Kidney Transplant DGF
Alexion announced that it has started dosing in its clinical trial evaluating eculizumab for the prevention of delayed graft function (DGF). The trial involves adult patients who have undergone kidney transplantation and who are at increased risk of DGF.
Eculizumab, also known commercially as Soliris, is a first-in-class terminal complement inhibitor approved in the U.S. and EU as well as other countries for the treatment of patients with the ultra-rare and life-threatening blood disorder paroxysmal nocturnal hemoglobinuria (PNH). The drug is also approved for treatment of ultra-rare genetic disorder atypical hemolytic uremic syndrome (aHUS). Eculizumab was granted orphan drug designation in January this year by the U.S. Food and Drug Administration (FDA) for the prevention of DGF in patients who have received renal transplant. The following month, the European Commission also designated eculizumab as an orphan medicinal product for the prevention of DGF after solid organ transplantation.
The company is investigating eculizumab’s safety and efficacy in a double-blind, placebo controlled, multi-national study for the prevention of DGF in recipients of deceased-donor kidney transplants at increased risk of DGF. The trial’s primary endpoint is incidence of DGF that would require dialysis in the first week following treatment.
Dr. Martin Mackay, EVP and global head of R&D at Alexion, said that DGF is a serious and life-threatening complication to kidney transplant operations due to the risk of the body rejecting the transplanted organ. “Since complement activation plays a critical role in the development of DGF, a terminal complement inhibitor like eculizumab may have the potential to prevent this devastating complication. In addition, as donor organs are in short supply, reducing the risk of DGF may allow more deceased-donor organs to be successfully transplanted, which could potentially shorten the waiting time to receive a transplant.”
Up to 20 percent of donor kidneys are thought to be unused and discarded every year in the U.S. and EU due to poor outcome related with DGF. As of today, no approved therapies exist for the prevention of DGF following kidney transplant.