Biopharmaceutical company Hansa Medical AB (STO:HMED) announced on Wednesday the finalisation of enrolment in the US investigator-initiated Phase II study with lead candidate IdeS in highly sensitised patients.

Reportedly, a total of 17 patients have been enrolled in the study at Cedars-Sinai Medical Centre with Professor Stanley Jordan as principal investigator. This study aimed at enrolling 10 to 20 patients.

According to the company, patients had donor specific antibodies (DSAs) and a positive cross -match test prior to IdeS treatment. IdeS effectively reduced the level of DSAs in all patients and turned the cross-match tests from positive to negative, thereby enabling transplantation for all patients.

All patients will be followed for six months with respect to safety, kidney function and DSA levels.

The results from 14 of these 17 patients were published in The New England Journal of Medicine on 3 August 2017 (Vol. 377 No. 5, pages 442-53).

Hansa Medical is developing novel immunomodulatory enzymes for transplantation and acute autoimmune diseases. The lead product, IdeS, is a proprietary antibody-degrading enzyme currently in late-stage clinical development for kidney transplant patients, with significant potential for further development in other solid organ transplants and in acute autoimmune indications.