Hansa Biopharma AB announced that results from its Phase 3 ConfIdeS study in kidney transplantation will be presented at the American Transplant Congress in 2026.
And not just presented normally.
The data has been selected as a late-breaking abstract for an oral presentation, which basically means the findings are considered important enough to be shared in one of the main spotlight sessions.
The meeting will take place in Boston on June 22, 2026.
The ConfIdeS study is a Phase 3 clinical trial focused on kidney transplant patients who are highly sensitized.
That term sounds technical, but it just means patients who already have strong immune system antibodies that can react badly to donor organs.
These antibodies are called donor-specific antibodies, or DSAs. They make transplantation much harder because the body may reject the new kidney.
So in simple terms, these are patients who have fewer transplant options and usually wait longer for a match.
The study is evaluating a treatment called imlifidase.
This drug is designed to break down a specific type of antibody called IgG antibodies.
IgG antibodies are part of the immune system, but in transplant patients, they can also attack a donated kidney.
So imlifidase is basically used to reduce or remove those antibodies before transplantation, so the body is less likely to reject the organ.
The upcoming presentation will include 12-month results from the trial.
It will cover:
The presentation will be given by Dr Robert Montgomery from NYU Langone Transplant Institute, who is also one of the investigators in the study.
The session is scheduled for June 22, 2026, during a late-breaking clinical science segment.
The primary endpoint in this trial is eGFR, which stands for estimated glomerular filtration rate.
This is basically a way to measure how well the transplanted kidney is working.
Higher values usually mean better kidney function.
So when the study talks about “superior 1-year eGFR,” it is trying to show that patients receiving imlifidase had better kidney performance after transplant compared to the control group.
Highly sensitized patients are not rare, but they are difficult to treat.
These patients have pre-formed antibodies that react against many donor organs.
Because of this:
In the U.S. and Europe, about 10 to 15 percent of patients on transplant waiting lists fall into this category.
So even though it is a smaller group, the clinical need is very high.
Imlifidase is an enzyme therapy.
It works by cutting up IgG antibodies in the blood.
These are the same antibodies that can trigger rejection of a donor kidney.
By breaking them down quickly, the treatment creates a short window where transplantation becomes possible.
It is already conditionally approved in parts of Europe under the brand name IDEFIRIX for certain kidney transplant patients.
IDEFIRIX is currently used in highly sensitized adult patients who otherwise would have very limited chances of receiving a transplant.
Imlifidase is not completely new.
It already has conditional approvals in:
In the United States, it is still under regulatory review.
The FDA has already accepted its Biologics License Application and is expected to make a decision by December 19, 2026.
Kidney failure is a major global health issue.
End-stage renal disease happens when kidney function drops below a critical level, and patients often need dialysis or a transplant.
Transplant is generally preferred because:
But the problem is simple: there are not enough compatible donor kidneys.
So patients with high antibody sensitivity face even fewer options.
Medical conferences like the American Transplant Congress are where key clinical trial results get reviewed by doctors, researchers, and policymakers.
A late-breaking oral presentation usually means:
So this is not just a routine update. It is part of the final stages of evaluating whether this therapy becomes a standard option.
The company is focused on developing treatments that modify the immune system in a controlled way.
Their main technology is based on enzymes that can remove IgG antibodies.
Beyond kidney transplantation, they are also exploring applications in:
Their goal is basically to solve situations where the immune system becomes a barrier to treatment.
Here is the simple version.
This upcoming presentation is about showing 12-month results from a Phase 3 kidney transplant study using imlifidase.
The key idea is that the drug may help patients who previously had very low chances of receiving a kidney transplant because of immune system antibodies.
The data is not final regulatory approval in the U.S., but it is an important step in showing whether this approach actually improves kidney function and transplant outcomes over time.