Novartis terminates Phase 2 iptacopan study for lupus nephritis

Novartis has terminated its Phase 2 clinical study of iptacopan (LNP023) for the treatment of active lupus nephritis. The study, which was designed to evaluate the efficacy, safety, and tolerability of the drug when used alongside standard care, was concluded due to ‘strategic considerations’ after the final participant in the first part of the trial completed their last visit.

Iptacopan, marketed under the brand name Fabhalta, is an oral complement Factor B inhibitor already approved by the U.S. Food and Drug Administration (FDA) for Paroxysmal Nocturnal Hemoglobinuria, Primary Immunoglobulin A Nephropathy, and C3 Glomerulopathy. It remains unclear whether the decision to end the lupus nephritis trial was based on safety, efficacy, or other strategic factors.

This discontinuation follows a series of recent clinical setbacks for Novartis, including late-stage trial failures for Pelacarsen, intended for cardiovascular risk reduction, and del-desiran, intended for myotonic dystrophy type 1. The company also recently discontinued the development of VHB937.