With a late-stage win in hand, Sweden’s Hansa Biopharma is one step closer to bringing its kidney transplant drug to the U.S.
Thursday, the company reported positive top-line results from a U.S. phase 3 trial of its antibody-cleaving enzyme imlifidase, which boasts conditional nods in the EU and several other countries to ease the kidney transplant process for certain patients with end-stage renal disease.
Kidney transplantation is preferred over dialysis for patients in that stage of disease, but the waitlist for an organ match in the U.S. is long and growing each year, executives at Hansa said on a call with analysts Thursday. Additionally, highly sensitized patients have even more difficulty finding a kidney match, due to their bodies producing high levels of antibodies that are meant to attack foreign tissues.
In turn, Hansa has developed imlifidase to rapidly cleave Immunoglobulin G (IgG) antibodies and inhibit their activity within hours, theorizing that the suppressed IgG activity might prevent those patients’ bodies from fighting back against a donor organ.
Hansa’s phase 3 study evaluated kidney function over a year in highly sensitized patients who received either imlifidase prior to their transplant or a range of control treatment options. The efficacy of Hansa’s candidate was assessed using the estimated glomerular filtration rate (eGFR) measure, the company’s chief medical officer, Richard Philipson, M.D., said on Thursday’s call.
Those in the control arm received care options such as remaining on dialysis while awaiting a more compatible organ offer, transplantation using off-label desensitization approaches or transplantation with a compatible organ, Hansa noted in a press release.
The U.S. trial included a total of 64 participants, split evenly between those receiving imlifidase and a control treatment, Philipson explained.
Patients on imlifidase achieved statistically significant improvements in kidney function on the eGFR measure at the trial’s 12-month mark, satisfying the study’s primary endpoint.
Hansa’s drug was well tolerated and yielded a low incidence of infusion reactions, Philipson said. Other side effects tracked with the kidney transplant population more broadly and were generally considered unrelated to imlifidase, according to the CMO.
Hansa aims to seek an accelerated review of imlifidase at the FDA by the end of the year, the company’s chief executive, Renée Aguiar-Lucander, said Thursday. If all goes to plan, the company could expect to see a U.S. approval decision on its drug in the third quarter of 2026, she said.
Laying out the opportunity for a drug like imlifidase in the U.S., Hansa’s chief operating officer and U.S. chief, Maria Törnsén, noted that “[t]he unmet needs in the U.S. kidney transplant market are significant.” The highly sensitized patients Hansa is targeting make up about 10% to 15% of the roughly 100,000 people on the U.S. kidney transplant list, she added.
As Hansa eyes a potential launch, the company is focusing its attention on the roughly 200 centers offering kidney transplants around the U.S. Meanwhile, the company has already worked with about 25% of the U.S. transplant market through its clinical trials, providing a strong base to debut imlifidase in the event of an FDA approval, Törnsén said.
As Hansa gets closer to a potential launch, the company also plans to recruit a field team of about 20 account managers, the COO added.
“We are very confident that we have the right professionalization strategy in place to enable a successful launch in the U.S., assuming FDA approval,” she said.