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Completed enrollment in Hansa Medical’s international multi-center Phase II study Highdes

Regulatory information
Hansa Medical AB (Nasdaq Stockholm: HMED), a biopharmaceutical company focusing on novel immunomodulatory enzymes, announced today the completion of enrollment for the international multi-center study Highdes. 

The study aimed to recruit 15-20 patients. A total of 18 patients have been treated with the company’s lead candidate IdeS and subsequently transplanted at five clinics in the US and Europe. All treated and transplanted patients will be followed up for six months. The primary objective of the study - to turn a positive cross-match test into a negative and thereby enable kidney transplantation - has been accomplished in all 18 treated patients.

“The presence of donor-specific antibodies can turn a patient with a readily available donor into a practically un-transplantable patient with the only option to remain in dialysis”, said Christian Kjellman, Chief Scientific Officer at Hansa Medical AB.

“Long-term dialysis is associated with significant health risks and comparably poor quality of life. To the Highdes study, we have recruited patients who essentially have no prospect of receiving a transplant. For all those patients treated in the study, IdeS enabled kidney transplantation”, he continued.

Safety and kidney function is followed for all patients during the six month follow-up study period. Final results are expected during the third quarter of 2018.

This is information that Hansa Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below at 08:00 CET on January 4, 2018.