Idefirix

Applying a new enzymology platform to create a world where all people with high levels of antibodies can receive transplants without rejection.

The Problem

More than 37 million Americans suffer from kidney disease, including 800,000 who rely on dialysis to stay alive. While the standard of care for end-stage kidney disease is a transplant, only 21,000 donor organs were available last year, and more than 100,000 patients remain on the list. In most cases, an available organ does not match, leading to antibody-driven rejection.

The Opportunity

Idefirix (imlifidase) is the first treatment that enables life-saving transplants of mismatched organs to those who would otherwise have to face long-term dialysis and early death by inhibiting an IgG-mediated immune response. Imlifidase is a novel injectable enzyme that transforms a mismatched organ into a match, prevents the body from rejecting a newly transplanted kidney, and thereby immensely increases access to life-saving transplants.

(Creative concept)

The Approach:

“Sorry, it’s not a match.” How many times have patients heard this while waiting for a compatible donor? Many wait for years. Almost every potential donor typically results in a mismatch, and the transplant doesn’t happen. New Idefirix converts a mismatch to an ideal match with a single, 15-minute infusion. Once administered, Idefirix rapidly cleaves HLA antibodies, eliminating them within hours, creating a match that’s made to last: in clinical studies, all patients not only received a matching kidney, but the kidneys remained functional throughout the 6-month study.

Idefirix is the first and only treatment that lets transplant surgeons tell almost every patient with high levels of HLA antibodies, “It’s a match. The transplant is on!” Because every patient deserves to find their perfect match.

(Creative concept)

Results

Since 2020, Idefirix has received a conditional marketing authorization valid throughout the EU, UK, Switzerland, Israel, and Australia.

"I am very pleased with the solid performance and strong progress across our R&D and commercial operations"

– Søren Tulstrup, President and CEO, Hansa Biopharma AB