BioArctic AB:s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by the Washington University School of Medicine in St. Louis, has agreed with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to amend the clinical study (Tau NexGen) design to include a background anti-amyloid agent.
STOCKHOLM, Nov. 8, 2021 /PRNewswire/ -- BioArctic AB:s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by the Washington University School of Medicine in St. Louis, has agreed with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to amend the clinical study (Tau NexGen) 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 (AD), the Tau NexGen clinical trial leaders selected BioArctic and Eisai’s investigational anti-amyloid beta (Aβ) 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 (DIAD) 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. “We are very proud that DIAN-TU has selected lecanemab as the background anti-amyloid agent in the Tau NexGen study. The growing body of evidence around anti amyloid antibodies’ clearance of amyloid from the brain and how it potentially effects Alzheimer’s disease has led DIAN-TU to include and anti-amyloid antibody as background treatment in their tau study. The choice of lecanemab underlines the value of the Phase 2b results, showing profound clearance of amyloid plaques from the brain, slowed cognitive decline in people with early Alzheimer’s disease and a low frequency of amyloid-related imaging abnormalities-edema (ARIA-E) following treatment with lecanemab,” said BioArctic’s CEO Gunilla Osswald. This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval. For further information, please contact: Oskar Bosson, VP Communications and IR The information was released for public disclosure, through the agency of the contact persons above, on November 8, 2021, at 06:00 p.m. CET. About lecanemab (BAN2401) About the collaboration between BioArctic and Eisai About BioArctic AB This information was brought to you by Cision http://news.cision.com The following files are available for download:
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