Argenx discontinues Phase III Sjögren’s disease trial
argenx has revealed that it will discontinue the Phase III UNITY study of Vyvgart Hytrulo (efgartigimod subcutaneous – efgartigimod alfa and hyaluronidase-qvfc) in adults with moderate-to-severe Sjögren’s disease.
The company said the decision is based on the recommendation from an Independent Data Monitoring Committee (IDMC) to stop the study for futility following an interim analysis.
The IDMC concluded that the UNITY study is unable to meet its primary endpoint, but no new safety signals were identified.
“We are disappointed by this outcome, most of all for people living with Sjögren’s disease, who are still waiting for treatments that fundamentally change the course of their disease,” said Dr Luc Truyen, Chief Medical Officer at argenx. “Sjögren’s Disease is one of the most heterogeneous and complicated diseases in immunology, and unravelling the biology of complex diseases is at the heart of what we do. We will analyse these data in depth and share what we learn with the Sjögren’s community.”
Following study close and database lock, argenx says it will conduct a comprehensive analysis of the data to understand the study’s outcome and generate insights that may inform future research in Sjögren’s disease.
Vyvgart (efgartigimod alfa fcab) is a first-in-class human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. Vyvgart Hytrulo is a subcutaneous combination of efgartigimod alfa and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s Enhanze drug delivery technology to facilitate subcutaneous injection delivery of biologics.
Vyvgart is approved for generalised myasthenia gravis (gMG) and immune thrombocytopenia (Japan only). Vyvgart Hytrulo is approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP).
The primary endpoint of the UNITY trial was change from baseline in systemic disease activity, as measured by the clinical EULAR Sjögren’s Syndrome Disease Activity Index (clinESSDAI), at Week 48.