BioArctic’s partner Eisai has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401).
BAN2401 is an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer’s disease.
Based on a Phase 2b trial
The FDA’s Breakthrough Therapy designation for lecanemab is based on the recently published results of a Phase 2b clinical trial (Study 201) of 856 patients with mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s with confirmed presence of amyloid pathology. The proof-of-concept Study 201 explored the impact of treatment with lecanemab on reducing brain amyloid beta (Aβ) and clinical decline. In this study, pre-specified analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses, describes the BioArctic in a press release.
A Phase 3 study
In March 2021, the enrollment of 1,795 patients with early Alzheimer’s disease in the Phase 3 study of lecanemab, Clarity AD, was completed. The study’s primary endpoint is expected to be completed by the end of September 2022.
Additionally, the Phase 3 clinical study, AHEAD 3-45, is currently exploring lecanemab in individuals with preclinical Alzheimer’s disease, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains. Open label extension data from Phase 2b study (Study 201) detected rapid and increasing reduction of brain Aβ over time in individuals treated with lecanemab.
Read more: Interview Gunilla Osswald, CEO, BioArctic
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