Argenx disclosed that its drug Vyvgart failed to outperform placebo in a Phase 3 trial for patients with Sjogren's disease, a chronic autoimmune disorder. The company stopped the trial early after a data monitoring committee determined the primary endpoint would not be met, marking an unusual setback for the firm.
STAT reports that Argenx has accumulated a series of wins in autoimmune disorders, helping it become one of the world's largest biotech companies based on market capitalization. Despite this history, analysts from William Blair had projected $1.4 billion in peak sales for Vyvgart in Sjogren's disease. They described the trial as high risk, noting that patients with Sjogren's disease often exhibit high placebo responses. The trial was originally scheduled for completion next year.
Separately, the Food and Drug Administration flagged a potential safety signal involving investigational evenamide, a medicine from Newron Pharmaceuticals. MedPage Today reports that four deaths were reported among patients with treatment-resistant schizophrenia who received the drug in clinical trials. In April, the FDA halted patient enrollment in a Phase 3 trial for evenamide following the sudden death of a participant.
The enrollment hold remains in place at U.S. study centers, though enrollment continues in other countries and additional clinical sites are being added. The FDA's concern relates to the risk that some sodium channel blockers may trigger arrhythmias, which can lead to serious cardiovascular events or seizures.