Novartis has halted a phase 2b clinical trial of CFZ533 (iscalimab) in kidney transplant patients after interim data showed it was less effective than tacrolimus-based treatment in preventing organ rejection.
The CIRRUS-1 study, launched in Nov. 2018, involved 418 transplant patients and examined three different doses of iscalimab. The study aimed to assess the ability of CFZ533 to replace Calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing better renal function with a better safety and tolerability profile.
Iscalimab is a new, fully human, monoclonal antibody preventing cluster of differentiation 40 (CD40) pathway signaling and activation of CD40+ cell types. Earlier studies found iscalimab more effective than tacrolimus at maintaining the integrity of transplanted kidney cells — suggesting the drug could extend the life of transplanted organs.
Novartis, however, isn't giving up on the drug. It is still being tested in a phase 2 CONTRAIL trial in liver transplant patients, as well as in studies of patients with type 1 diabetes, lupus nephritis, Sjögren’s syndrome and the painful skin condition, hidradenitis suppurativa.