Roche's Complement Factor B Antisense Therapy RO7434656 Granted Clinical Trial Approval in China for IgA Nephropathy

On July 6, the CDE website showed that the clinical trial application for RO7434656 injection (IONIS-FB-LRx), an antisense therapy under development by Roche, received a default approval, with the indication being IgA nephropathy.

IgA Nephropathy is a glomerular disease characterized by the deposition of immune complexes predominantly composed of immunoglobulin A (IgA) in the mesangial area of the glomeruli, and it is also the most common primary glomerulonephritis worldwide. Studies show that the annual incidence rate of IgA nephropathy in the U.S. population is 21 per 100,000, with an even higher incidence in Asian populations.

IONIS-FB-LRx is an antisense therapy targeting complement factor B (CFB), designed to prevent kidney damage caused by complement activation in patients with IgA nephropathy at the source. The original research company of IONIS-FB-LRx is Ionis. In October 2018, Roche and Ionis reached a collaboration to jointly develop IONIS-FB-LRx for the treatment of complement-mediated diseases.

In November 2022, Ionis announced that the Phase II clinical trial of IONIS-FB-LRx for the treatment of IgA nephropathy met its primary endpoint. The study results showed that after 29 weeks of IONIS-FB-LRx treatment, patients' proteinuria decreased by an average of 44% from baseline; IONIS-FB-LRx also continuously reduced the levels of CFB, alternative pathway activity (AH50), and urinary complement fragment Ba. In addition, IONIS-FB-LRx treatment demonstrated good safety.

Based on the excellent Phase II data of IONIS-FB-LRx, in December 2022, Roche stated that it would actively advance the Phase III study of IONIS-FB-LRx for the treatment of IgA nephropathy and would be responsible for the drug's development and commercialization activities worldwide in the future.

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