Our mission is to enable organ transplant recipients and patients suffering from severe auto-immune or immune-mediated diseases to live healthy lives free from chronic immunosuppression.
The lead indication for our investigational cell therapy, FCR001, is to enable living donor kidney transplant recipients to discontinue all chronic immunosuppression therapy by twelve months after their transplant.
In a Phase 2 study of FCR001 that enrolled 37 living donor kidney transplant patients between 2009 and 2016, 70% of the patients who received our FCR001 therapy were able to stop taking all immunosuppressive drugs approximately one year after receiving their transplant. To date, every transplant recipient in our trial who was removed from immunosuppression has remained off all immunosuppression, with no signs of rejection, and with favorable ranges of kidney function. We have followed these patients for between two to nine years after their transplant. We expect to start a Phase 3 trial of FCR001 in living donor kidney transplant patients in 2019.