The company demonstrated a significant reduction in time on the waitlist for patients treated with imlifidase compared to matched controls at the 2019 American Transplant Congress, June 1 – 5, in Boston, Massachusetts, USA.
In a plenary presentation on June 5, 2019, Edmund Huang, Associate Professor and Transplant Nephrologist at the Kidney and Pancreas Transplant Center at Cedars-Sinai Medical Center in Los Angeles, presented “Three-year Outcomes of Highly-sensitized Kidney Transplant Recipients Desensitized with IgGEndopeptidase.” The plenary abstract, by Huang and Stanley Jordan, Director Kidney Transplantation and Transplant Immunology at the Cedars-Sinai Medical Center in Los Angeles, won the ATC’s People’s Choice Award, as voted by the ATC attendees to be the most impactful to the transplant community.
A statistically significant reduction in time
In his presentation, Huang reported a statistically significant reduction in time on the waitlist for transplantation among imlifidase treated patients compared to similarly sensitized matched controls. The matched control analysis showed statistically significant shorter time to transplant in both the current and previous U.S. Kidney Allocation System (KAS).
“Our matched control analysis showed statistically significant shorter time to transplant in the pre and post- KAS era. We are therefore convinced that Imlifidase complements the new KAS system and will facilitate reduced time to kidney transplantation in highly sensitized patients,” commented Huang
“We have previously demonstrated that treatment with imlifidase enables life-saving kidney transplantation that would otherwise not be possible. This matched control analysis further illustrates shorter time to transplant for these highly sensitized patients” commented Jordan.
Follow up data from Phase 2 study
The presentation also reported follow up data from the U.S. investigator-initiated Phase 2 study of imlifidase for kidney transplantation in highly sensitized patients. Results show excellent graft survival out to three years with graft survival in line with deceased donor transplantation of non-sensitized patients. One death, unrelated to imlifidase treatment and the kidney transplant, occurred 10 months after transplant. There were sporadic cases of late rebound DSA, but most remained DSA-free up to 36 months post-transplant.
In an oral presentation on June 2, 2019, Robert A. Montgomery, Director, NYU Langone Transplant Institute, New York City, presented “Safety and Efficacy of Imlifidase in Highly-Sensitized Kidney Transplant Patients: Results from a Phase 2 Study.”
“The safety and efficacy data on imlifidase provide hope to highly sensitized patients, who today are very difficult or impossible to transplant, and face an extremely poor prognosis. Six months follow up results continue to show that imlifidase has enabled all patients to undergo transplantation resulting in good kidney function and graft survival,” said Robert A. Montgomery.
Transplant rates could be increased by 25%
In a poster session on June 2, 2019, Matthew J. Everly, Director of the Terasaki Research Institute in Los Angeles, presented “A Prognostic Drug Development Tool to Assess the Transplantability at the Time of Listing for Kidney Transplant Candidates.”
In his poster session Everly reported on the results of simulations done in highly sensitized patients, which demonstrated that transplant rates could be increased by 25% if there were a therapy to address the HLA antibody barrier.