Hansa Medical AB (STO:HMED), a biopharmaceutical company developing novel immunomodulatory enzymes for organ transplantation and acute autoimmune diseases, announced on Thursday the successful completion of two phase 2 clinical studies of imlifidase for kidney transplantation in highly sensitised patients, enabling transplantation in all 35 patients.
These trials were single arm, open label studies to assess the safety and efficacy of imlifidase with either a deceased or living donor kidney. The studies enrolled a total of 35 highly sensitised patients who had either failed previous attempts of desensitisation or were highly unlikely to receive a compatible kidney transplant.
Reportedly, the Hansa Medical sponsored multicentre Highdes study
enrolled 18 patients at five sites in the US, France and Sweden, while the US investigator-initiated study enrolled 17 patients at the Kidney and Pancreas Transplant Centre at Cedars-Sinai Medical Centre, Los Angeles.
According to the company, the results of these studies were that Imlifidase met all primary and secondary endpoints in both studies. Also, treatment with imlifidase enables highly sensitised patients to receive lifesaving transplants.
Hansa Medical plans to submit BLA and MAA filings for imlifidase in Q4 2018 or Q1 2019.
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