The study’s primary objective includes assessment of graft survival in patients who have undergone kidney transplantation after treatment with imlifidase.
It intends to encompass all patients from the phase II studies with imlifidase in sensitized kidney transplantation patients.
Imlifidase (INN), also known as IdeS, is an enzyme that is claimed to deplete IgG antibodies quickly and effectively.
The enzyme is being developed by Hansa Medical as a treatment to allow kidney transplantation in sensitized patients, who were previously unable to kidney transplantation because of the presence of anti-HLA IgG antibodies.
Efficacy data reported from three phase II studies showed that imlifidase rapidly and significantly reduced anti-HLA antibodies, allowing kidney transplantation.
Hansa Medical is presently assessing Imlifidase in two studies in highly sensitized patients that do not respond to available desensitization methods.
Results from these studies are expected to come in the third quarter of this year and the plan is to submit the applications for market approval, biologics license application (BLA) in the US and Market Authorization Application (MAA) in the EU by the end of this year or early next year.
The primary outcome measure of this study is to evaluate graft survival during the 5-year time frame in patients who have undergone kidney transplantation after imlifidase treatment.
The rationale for the study is to collect data from extended follow up in patients who have received kidney transplant after imlifidase dosing to provide a better understanding regarding the long-term outcome for such patients.
Data parameters such as patient and graft survival along with quality of life will be collected and the study will provide important information to future prescribers and patients on long-term outcome of imlifidase mediated transplantation.
In early July, Hansa Medical secured approval for imlifidase from the US Food and Drug Administration (FDA) for treating anti-GBM antibody disease (anti-GBM), also known as Goodpastures disease, a severe kidney disease where the immune system mistakenly develops IgG-antibodies that results in an acute immune attack on the kidneys.
