In spite of the ongoing controversy around their Alzheimer’s antibody, Aduhelm (aducanumab), partners Biogen and Eisai are pushing ahead with a second candidate antibody, lecanemab.
Lecanemab (previously known as BAN2401) is an anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer’s disease (AD), targeting the same pathway as Aduhelm but with a different mechanism.
Granted breakthrough therapy designation by the Food and Drug Administration in June, Biogen and Eisai are submitting the biologics licence application based on data from the proof-of-concept, phase 2 clinical trial (Study 201) in people with early AD and confirmed amyloid pathology.
In the trial, lecanemab demonstrated “a high degree of Aβ plaque lowering and consistent reduction of clinical decline across several clinical endpoints”, said the companies.
However, as with Aduhelm, Biogen and Eisai cite only a correlation between Aβ plaque reduction and clinical endpoints, which “supports Aβ as a surrogate endpoint that is reasonably likely to predict clinical benefit”.
The FDA has agreed that the currently underway Clarity AD phase 3 clinical trial can serve as the confirmatory study to verify the clinical benefit of lecanemab. The trial completed its enrolment of 1,795 patients in March and the primary endpoint is expected to be completed in September 2022.
Biogen and Eisai are also exploring lecanemab in a phase 3 study, AHEAD 3-45, in people with preclinical AD, which means they have intermediate or elevated levels of amyloid in their brains but are “clinically normal”.
“AD imposes an enormous burden on not only people living with AD and their families but also for society,” said Eisai CEO, Haruo Naito. “The lecanemab rolling BLA submission marks a new milestone toward the advancement of a treatment system for AD.”
Biogen CEO, Michel Vounatsos, said: “We believe that treatments directed at amyloid beta reduction in the brain have the potential to transform diagnosis and treatment of Alzheimer’s disease.”
Lecanemab was originally developed at the biotech company BioArctic Neuroscience, in partnership with Eisai, which them teamed up with Biogen in 2014.
Biogen and Eisai’s antibody is not the only one in its class reaching late stage development. In June, Eli Lilly received breakthrough therapy designation for its Alzheimer’s therapy, donanemab. Its safety, tolerability and efficacy are currently being evaluated in the ongoing phase 3 study TRAILBLAZER-ALZ 2.