BioArctic AB (publ) partner Eisai announced that the Dominantly Inherited Alzheimer Network Trials Unit, led by the Washington University School of Medicine in St. Louis, has agreed with the U.S. Food and Drug Administration and the European Medicines Agency to amend the clinical study design to include a background anti-amyloid agent. The Tau NexGen clinical study was originally designed to focus on therapies that target tau. With increasing evidence from clinical studies showing that targeting amyloid can affect biomarkers of Alzheimer?s disease, the Tau NexGen clinical trial leaders selected BioArctic and Eisai?s investigational anti-amyloid beta protofibril antibody lecanemab as the background anti-amyloid agent. The purpose of the Tau NexGen study is to assess the safety, tolerability, biomarker and cognitive efficacy of investigational therapies in people who have an Alzheimer's disease-causing gene mutation. The study will evaluate if treatment with study drug slows the rate of progression of cognitive impairment and improves disease-related biomarkers. People who have this genetic mutation of dominantly inherited Alzheimer?s disease are known to develop AD and will likely develop symptoms at around the same age their affected parents did, often in their 50s, 40s or even 30s. In March 2021, DIAN-TU selected Eisai?s tau antibody E2814, as the first investigational medicine among anti-tau drugs for the DIAN-TU tau study.