Data from Pharmawand - Curated by EPG Health - Date added 07 August 2018
Hansa Medical initiates follow up study of patients treated with lead candidate imlifidase (IdeS) prior to kidney transplantation. Hansa Medical announced that a long-term observational prospective follow up study (ClinicalTrials.gov Identifier: NCT03611621) has been initiated with Hansa Medical as sponsor. The primary objective of the study is evaluation of graft survival in patients who have undergone kidney transplantation after treatment with imlifidase.
The study aims 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 depletes IgG antibodies fast and effectively. Hansa Medical is developing imlifidase as a proprietary treatment to enable kidney transplantation in sensitized patients, previously unable to undergo kidney transplantation due to the presence of anti-HLA IgG antibodies. Efficacy data reported from three Phase II studies have demonstrated that imlifidase rapidly and significantly reduced anti-HLA antibodies, enabling kidney transplantation.
Imlifidase is currently being evaluated in two studies in highly sensitized patients that do not respond to available desensitization methods. Results from these studies are expected in late Q3 2018 and the goal is to submit applications for market approval, Biologics License Application (BLA) in the US and Market Authorization Application (MAA) in the EU, at the end of 2018 or early 2019.
The initiated long-term observational prospective follow up study (ClinicalTrials.gov Identifier: NCT03611621) aims to encompass all patients from the Phase II studies with imlifidase in sensitized kidney transplantation patients. The primary outcome measure of the study is evaluation of graft survival during a 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 that have received a kidney transplant following imlifidase dosing to provide a better understanding regarding the long-term outcome for these patients. Data of parameters such as patient and graft survival as well as quality of life will be collected. This prospective, observational follow up study of patients who have received imlifidase prior to kidney transplantation will provide important information to future prescribers and patients on long-term outcome of imlifidase mediated transplantation.