Swedish biopharmaceutical company Hansa Medical has reported topline results from its Phase II study of IdeS for kidney transplantation.
Immunoglobulin G-degrading enzyme of Streptococcus pyogenes (IdeS) is an enzyme based on a novel mechanism specifically designed to cleave human IgG antibodies.
It inactivates human IgG antibodies, to prevent and treat patients who have developed pathogenic IgG.
The Phase II study involved ten patients administered with single doses of IdeS prior to kidney transplantation.
The study is primarily focused on determining the safety and tolerability of IdeS within sensitised kidney transplantation patients.
It is also aimed at determining the IdeS dose that leads to anti-HLA antibody levels acceptable for transplantation within 24 hours from dosing.
The patients involved in the study were followed for six months after transplantation to assess the drug safety and kidney function.
Preliminary results suggested that IdeS has enabled kidney transplantation, resulting in a negative cross match test in all patients with no events of delayed graft function recorded.
All ten transplantations also resulted in good creatinine levels.
Hansa Medical is also conducting two other clinical studies with IdeS in sensitised patients, consisting of an investigator-initiated Phase II study at the Cedars-Sinai Medical Center in Los Angeles and a pivotal multicentre study in the US with IdeS in refractory, highly sensitised patients.