Biogen and Eisai have announced positive top-line results from a phase 3 trial of lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD, collectively known as early AD.
Early AD is a form of dementia, with symptoms gradually becoming more severe, and there are limited treatment options available. These symptoms typically include confusion, memory loss, disorientation and significant changes in mood or behaviour.
Eisai’s Clarity AD trial was a global phase 3 confirmatory placebo-controlled, double-blind, parallel-group, randomised clinical trial to assess a 10mg/kg bi-weekly dosage of lecanemab in 1,795 people with early AD.
The company’s recruitment strategy ensured greater inclusion of ethnic and racial populations in the US, resulting in Hispanic and African American people living with early AD being included in approximately 25% of the total US enrolment.
The study met its primary endpoint and reduced clinical decline by 27% on the global cognitive and functional scale – Clinical Dementia Rating-Sum of Boxes (CDR-SB) – compared with placebo at 18 months. All key secondary endpoints were also met, the companies said.
Haruo Naito, chief executive officer at Eisai, said: “Eisai believes these findings will create new horizons in the diagnosis and treatment of Alzheimer’s disease, as well as further activate innovation for new treatment options.”
The US Food and Drug Administration (FDA) accepted Eisai’s Biologics Licence Application for lecanemab under the accelerated approval pathway and granted Priority Review in July 2022, setting a Prescription Drugs User Fee Act action date of 6 January 2023.
The FDA has agreed that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.
Michel Vounatsos, chief executive officer at Biogen, said the announcement “gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer’s disease and provide a clinically meaningful impact on cognition and function”.
Eisai outlined that it will discuss the data with regulatory authorities in the US, Japan and Europe, and aims to file for traditional approval in the US, as well as marketing authorisation applications in Japan and Europe, by 2023.
The company will also present the Clarity AD study results at the Clinical Trials on Alzheimer’s Congress in November and publish the findings in a peer-reviewed medical journal.