Johnson & Johnson detailed positive data from a mid-stage trial in people with Sjögren’s disease that, according to some analysts, could be an encouraging signal for the FcRn inhibitor class that includes argenx’s Vyvgart.
J&J’s candidate, dubbed nipocalimab, is hot on the heels of argenx’s Vyvgart as the Dutch biotech said in March it would advance its drug into Phase 3 development for Sjögren’s disease.
In the 163-subject DAHLIAS trial, the 15 mg/kg nipocalimab dose was better than placebo according to the so-called ClinESSDAI score, which measures symptoms of Sjögren’s disease, at 24 weeks (p=0.002). These primary endpoint data were presented at the European Alliance of Associations for Rheumatology annual congress on Saturday.
Nipocalimab was also linked with “clinically meaningful” improvements in secondary endpoints, including multiple organ assessments and physician assessments, according to a company release. J&J in February teased the DAHLIAS trial was successful but did not detail the results.
Saturday’s data establish proof of concept for nipocalimab in Sjögren’s disease and justify further development of the program, study investigator Jacques-Eric Gottenberg, professor at Strasbourg University Hospital’s Department of Rheumatology, said in the release.
William Blair analysts wrote Monday that the nipocalimab data also support argenx’s decision to advance Vyvgart into Phase 3 for Sjögren’s disease. In March, argenx said it had Phase 2 data to back this move, although it has yet to detail the results.
Vyvgart won US approval for generalized myasthenia gravis (gMG) back in 2021, with a more convenient subcutaneous formulation greenlit around a year ago. The drug has benefitted commercially from its first-in-class status, reaching $1.19 million in full-year 2023 sales.
Sjögren’s disease affects around four million people worldwide, according to J&J. Current standard of care focuses on reducing symptoms rather than addressing the root cause of the disease, such as using nonsteroidal anti-inflammatory drugs for joint pain.
Editor’s note: The headline of this article was updated to correct that Sjögren’s disease is not a rare disease.