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Finalized enrollment in US Phase II study with IdeS in highly sensitized patients

Regulatory information
Hansa Medical AB (Nasdaq Stockholm: HMED), a biopharmaceutical company focusing on novel immunomodulatory enzymes, announced today that enrollment has been finalized in the US investigator-initiated Phase II study with lead candidate IdeS in highly sensitized patients. 

A total of 17 patients have been enrolled in the study (ClinicalTrials.gov Identifier: NCT02426684) at Cedars-Sinai Medical Center with Professor Stanley Jordan as principal investigator. The study aimed at enrolling 10 to 20 patients. 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. Professor Jordan commented on the problem of sensitization and how IdeS has improved transplant rates for these patients:

“HLA sensitization is a major barrier to kidney transplantation. Despite advancements in desensitization, effective methods to remove incompatible HLA antibodies remains a significant challenge in transplantation. There are currently no approved treatments for desensitization and there is a significant unmet medical need for new therapies to address this issue”, he continued,

“Our study shows that IdeS cleaves IgG antibodies remarkably fast and effectively, with a favorable safety profile. This unique and completely novel mechanism of action has enabled kidney transplantation for patients where previous attempts at desensitization have failed. We have managed to transplant patients that have been on dialysis for more than 25 years.”

The results from 14 of these 17 patients were published in The New England Journal of Medicine on August 3, 2017 (Vol. 377 No. 5, pages 442-53). In the article, titled IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation, researchers demonstrated that treatment with IdeS is effective in reducing donor-specific antibodies (DSAs) to levels allowing lifesaving kidney transplantation of highly sensitized patients. The publication in The New England Journal of Medicine covered three separate studies, performed in Sweden and the US, and included 25 HLA-sensitized patients who received IdeS immediately before kidney transplantation.

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 above at 08:00 CET on January 3, 2018.