Novartis' Fabhalta Demonstrates Significant Proteinuria Reduction In IgA Nephropathy Patients

(RTTNews) - Novartis (NVS) presented results from a pre-specified interim analysis of the Phase III APPLAUSE-IgAN study of Fabhalta (iptacopan), an investigational Factor B inhibitor of the alternative complement pathway, in patients with IgA nephropathy or IgAN. Results were presented during a late-breaking clinical trials session at the World Congress of Nephrology in Buenos Aires, Argentina.

In the analysis, patients treated with Fabhalta achieved a 38.3% proteinuria reduction--as measured by 24-hour urine protein to creatinine ratio-- at 9 months when compared to placebo on top of supportive care, the company said in a statement.

Proteinuria reduction is an increasingly recognized surrogate marker correlating with progression to kidney failure and has been used as an endpoint in IgAN clinical trials to support accelerated approvals.

The study also showed that Fabhalta was well tolerated with a favorable safety profile consistent with previously reported data.

According to the company, the pre-specified interim analysis included 250 patients for the efficacy analysis and 443 for the safety analysis. The APPLAUSE-IgAN study continues in a double-blind fashion, and therefore only limited interim analysis results can be presented. Submission for possible accelerated approval to the FDA was accepted and has received priority review.

The primary endpoint evaluating Fabhalta's ability to slow IgAN progression by measuring the annualized total estimated glomerular filtration rate (eGFR) slope over 24 months is expected at study completion in 2025.

In addition to Fabhalta, Novartis is advancing the development of two other therapies in IgAN with highly differentiated mechanisms of action: atrasentan, an investigational oral endothelin A (ETA) receptor antagonist, and zigakibart, an investigational subcutaneously administered anti-APRIL monoclonal antibody, which are both in Phase III development, the company said.

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