Hansa Biopharma Reports First Patient Enrollment in (ConfIdeS) Trial of Imlifidase for the Treatment of Patients with Kidney Transplant
Shots:
- The first patient has enrolled in a (ConfIdeS) trial to evaluate imlifidase in 64 highly sensitized kidney transplant patients with a cPRA of ≥99.9% across Columbia University Medical Center. The enrollement is expected to be completed in H2’22 with a 12mos. follow-up study completed in H2’23
- The 1EPs of the study is to evaluate benefit in transplanting highly sensitized patients i.e., kidney graft function @12mos. as measured by eGFR
- The results will support a BLA submission to the FDA under the accelerated approval in H1’24. Imlifidase has received conditional marketing approval in the EU for the desensitization treatment of highly sensitized adult kidney transplant patients
Ref: PR Newswire | Image: Hansa
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