Eisai and Biogen Announce Positive Phase 2 and Open-Label Extension Data for Lecanemab in Early Alzheimer’s Disease

Compiled by Aspirin

U.S. Eastern Time, November 11, 2021 – Eisai and Biogen announced positive data from the ongoing Phase II clinical and open-label extension study of lecanemab for the treatment of early Alzheimer's disease (AD). Open-label extension studies are generally considered to enhance the data of clinical trials, with a focus on gathering more rigorous information about the long-term safety and tolerability of new drugs.

Eisai and Biogen's latest findings evaluated the reduction of amyloid plaques in patients' brains after using the drug, across clinical, biomarker, and safety aspects. According to PET measurements, the open-label extension study demonstrated the drug’s clinical benefits in reducing brain amyloid levels in as fast as three months, with over 80% of trial participants showing significant amyloid clearance between 12 to 18 months. The open-label extension study is set to last for five years.

It is reported that Eisai and Biogen reached a co-development and commercialization agreement for lecanemab in October 2017. Following promising results from the disclosed Phase II trial, both companies are currently conducting a Phase III clinical study on patients with early symptomatic Alzheimer’s disease. A Phase III clinical study (Ahead 3-45) targeting preclinical Alzheimer’s disease patients began in July 2020. Preclinical Alzheimer’s disease refers to individuals who are clinically normal but have moderate or significantly elevated levels of amyloid protein in the brain compared to normal levels.

During the open-label extension study, patients received 10 mg/kg of lecanemab intravenously every two weeks. The study found that lecanemab may have disease-modifying effects as measured by biomarkers, amyloid PET, plasma Aβ 42/40, and p-tau181. Plasma Aβ 42/40 and plasma p-tau181 are two new blood tests (plasma biomarkers) that can be used alongside PET to monitor treatment effects.

"The latest findings on lecanemab provide deeper insights into the time course and extent of amyloid reduction by lecanemab, as well as the relationship between clinical outcomes and blood-based biomarkers. The Phase 3 Clarity AD study for early Alzheimer's patients completed enrollment of 1,795 participants in March this year to validate these findings," said Dr. Lynn Kramer, Chief Clinical Officer of Eisai's Neurology Business Group, in a statement.

Notably, in September this year, Eisai and Biogen announced that they had started a rolling submission of a Biologics License Application (BLA) for lecanemab, intended for the treatment of early Alzheimer's disease, to the U.S. FDA through the accelerated approval pathway.

Reference Source: Eisai-Biogen Alzheimer's Drug Shows Amyloid Reduction, Disease-Modifying Effect