In June 2022, Xenikos commenced a global Phase 3 clinical study evaluating T-Guard® in patients with grade III/IV steroid-refractory acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplant (NCT04934670). In early 2023, following a review of the ongoing study data the Data Safety and Monitoring Board (DSMB) recommended that the study should be discontinued. Although we feel that the DSMB’s conclusion may be premature, patient safety is our highest priority; therefore, the study has been stopped, and Xenikos has decided to cease operations.
During this difficult time, we wish to extend our sincere gratitude to the patients and their families, as well as our employees, investors, and partners for their support throughout this journey. Even though T-Guard did not reach the end of Phase 3 testing, we believe that our data will contribute to future research regarding this and other devastating diseases. It is also currently being explored whether T-Guard can be further developed for other clinical indications.
T-Guard® is a medicine currently under development that safely and swiftly ‘resets’ the body’s immune system. It shows potential in the effective treatment of certain life-threatening immune conditions, such as transplant-related rejection, acute graft-versus-host disease (aGVHD), solid-organ rejection and several severe autoimmune diseases.