Positive trial results reported on transplant drug for sensitized patients
Biopharmaceutical company Hansa Medical AB reported in a press release that Imlifidase, its immunosuppressive transplant drug for highly sensitized patients, met all primary and secondary endpoints in two phase 2 studies in the United States and other countries.
The Lund, Sweden-based biopharmaceutical company said the multicenter Highdes trials enrolled 35 highly sensitized patients who had either failed previous attempts of desensitization or were highly unlikely to receive a compatible kidney transplant. Either a deceased or living donor kidney was used for transplantation.
Imlifidase is an enzyme that specifically cleaves IgG antibodies, thereby inhibiting the IgG-mediated immune response, the company said. Hansa Medical is developing Imlifidase as a proprietary treatment to enable kidney transplantation in sensitized patients, previously unable to undergo transplant surgery due to the presence of donor-specific antibodies.
The trial results showed Imlifidase was used successfully in all 35 highly sensitized patients. Graft survival at study completion, 6 months post-transplantation, was 91%, Hansa reported. Thirty-two of those patients were off dialysis with good kidney function, with eGFR within the expected range. Three patients experienced graft loss unrelated to the treatment with Imlifidase, the company reported.
“Imlifidase continues to demonstrate strong risk-benefit profile in breaking down this previously insurmountable immunological barrier, enabling transplantations that otherwise would not be possible to perform,” Stanley Jordan, MD, director of Kidney Transplantation and Transplant Immunology at the Kidney and Pancreas Transplant Center at Cedars-Sinai Medical Center, Los Angeles, and lead investigator in one of the four trials, said in the release.
“These patients are difficult or impossible to transplant, and face an extremely poor prognosis, with mortality rates on dialysis exceeding that of most forms of cancer,” Robert A. Montgomery, MD, director of the NYU Langone Transplant Institute and lead investigator of the Highdes study, said in the release.
Patients had a median calculated panel reactive antibody (cPRA) of greater than 99.5%, with over half having a cPRA of 100%. The mean time on dialysis prior to Imlifidase treatment and transplantation was greater than 7 years. Most patients had previous failed kidney transplants.
“Our ambition now is to seek a path towards regulatory approval from the U.S. Food and Drug Administration and the European Medicines Agency based on the strong clinical data generated to date, and we expect to file for marketing authorization in Q4 2018 or Q1 2019,” Søren Tulstrup, president and CEO of Hansa Medical AB, said in the release.