Our Phase 2 Clinical Data

Our Phase 2 Results

Talaris’ FCR001 investigational therapy has shown the potential to improve long-term quality of life and to allow transplant recipients to return to a more normal, immunosuppression-free life. In a Phase 2 clinical study conducted between 2009 – 2016 at two leading US transplant centers, Talaris’ investigational therapy enabled 26 of 37 participating kidney transplant recipients to be weaned off all chronic immunosuppressive drugs by twelve months after their transplant. Our therapy worked just as well for transplant recipients with a low degree of immune system match to the donor as it did for transplant recipients with a high degree of immune system match to the donor. Every patient who was taken off immunosuppression as a result of our therapy continues to remain off immunosuppression without rejection of the transplanted organ. These patients have been followed for between two to nine years since their transplant.

All seven transplant recipients who originally required a kidney transplant because of a kidney-related autoimmune condition and who were successfully tolerized with our therapy have thus far remained free of their prior autoimmune disease. Moreover, we recently reported that our Phase 2 patients who were successfully weaned off all immunosuppression and who are at least five years post-transplant generally have better kidney function and much lower rates of high blood pressure and high cholesterol compared to patients who received standard kidney transplants at the same transplant center during the same timeframe.

Here is a publication summarizing our Phase 2 study and the early results.

“Talaris’ therapy has demonstrated impressive results in a Phase 2 study, enabling a high percentage of living donor kidney transplant recipients to develop durable immune tolerance, without need for immunosuppression, even when there was significant HLA-mismatch between the donor-recipient pairs. I am excited to see this promising therapy advance into a Phase 3 pivotal study.”

— Josh Miller, MD, Founder and Former President, American Society of Transplant Surgeons