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September 6, 2021

Novartis to discontinue trial of CFZ533 in kidney transplant patients

Interim analysis data from the trial showed that treatment with CFZ533 was less effective in averting organ rejection. 

Novartis has decided to discontinue the CIRRUS-1 clinical trial of experimental compound CFZ533 (iscalimab) in kidney transplant patients due to reduced efficacy.

A novel, fully human, monoclonal antibody, CFZ533 can potentially hinder cluster of differentiation 40 (CD40) pathway signalling and activation of CD40+ cell types.

The company announced plans to discontinue the trial following an interim analysis of data from the trial.

According to the findings, CFZ533-based therapy was less efficacious as against tacrolimus-based treatment in hindering organ rejection in patients who have had a kidney transplant.

Novartis noted that CFZ533, as well as tacrolimus, were analysed in combination with various immunosuppressive treatments including induction therapy, mycophenolate and corticosteroids, in the trial.

In a multicentre, randomised control trial, CFZ533 demonstrated to be non-inferior on a composite clinical goal, enhanced renal function, reduced the risk of new-onset diabetes and safety profile in line with tacrolimus.

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The trial of CFZ533 in liver transplant patients is underway.

The drug is also being analysed as a potential therapy for other conditions, including hidradenitis suppurativa and Sjögren’s syndrome.

The review of the data from the CIRRUS-1 study is progressing and will be shared with the wider scientific community on the conclusion.

Last month, the US Food and Drug Administration (FDA) lifted the partial clinical trial hold on Novartis’ intrathecal (IT) OAV-101 (AVXS-101) programme for patients with spinal muscular atrophy.

The agency placed the partial clinical hold in October 2019 based on findings from a pre-clinical animal study.

The move came after the FDA analysed data from the company’s non-clinical toxicology study in non-human primates that addressed all detected issues, including questions related to dorsal root ganglia injury after IT injection.

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