ADIENNE aims to establish begelomab as standard treatment for steroid-resistant acute Graft-versus-Host Disease (sr-aGvHD). sr-aGvHD is a life threatening disease caused by the reaction of the donor immune cells against the recipient’s tissue antigens (alloreaction) for which currently no approved drug and no universally accepted standard of care exists.
Begelomab is ADIENNE’s lead clinical product candidate that is currently undergoing a registrative Phase II/III clinical trial in steroid-resistant acute Graft-versus-Host Disease. In parallel, ADIENNE plans to achieve a label extension of begelomab as a second line therapy in SAA where standard immunosuppressive agents have failed. SAA results from a reduction in the number of multipotent stem cells combined with an inability of existing cells to repopulate bone marrow.
Begelomab has been granted ODD for the treatment of GvHD in the U.S., E.U. and Switzerland.