Eisai and Biogen announce positive results for amyloid-lowering drug lecanemab which slowed cognitive decline in large, Phase 3 clinical trial.
Japanese pharma company Eisai and Biogen, a biotech based in Cambridge, Massachusetts, have announced positive topline results from Eisai’s large global Phase 3 confirmatory Clarity Alzheimer’s clinical trial of lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease and mild Alzheimer’s (collectively known as early Alzheimer’s) with confirmed presence of amyloid pathology in the brain.
Longevity.Technology: Drugs for Alzheimer’s have a rather chequered history; Biogen’s aducanumab (marketed as Aduhelm) was approved last year, making it the first Alzheimer’s medication in nearly 20 years to actually slow the progression of Alzheimer’s disease, rather than just ameliorating the symptoms. With one commentator calling the data “incomplete and contradictory”, the FDA approval caused turmoil, triggering the resignations of three FDA advisors and confusion in among patients, healthcare providers and insurance companies.
So, while these latest trial results give a glimmer of hope that Alzheimer’s research is moving in the right direction, the still-to-be peer-reviewed impact is small. Cautious optimism is advised.
Lecanemab met the primary endpoint CDR-SB: Clinical Dementia Rating-Sum of Boxes, which qualified healthcare professionals assessed cognitive and functional performance in six areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care.
It also met all key secondary endpoints, which included the change from baseline at 18 months compared with placebo of treatment in amyloid levels in the brain measured by amyloid positron emission tomography (PET) and various cognitive impairment indicators.
According to a statement released by the companies, lecanemab reduced clinical decline on the global cognitive and functional scale by 27% compared with placebo at 18 months; the trial involved 1,795 patients .
“Since Eisai launched Aricept in the US and Japan in the late 1990s and obtained its approval in over 100 countries, Eisai has provided the drug to people living with dementia while building empathy for them and their families through disease education efforts and community involvement,” said Haruo Naito, Chief Executive Officer at Eisai.
“The positive result of the lecanemab, an anti-Aβ protofibril antibody, pivotal study after almost 25 years since Aricept’s launch is an important milestone for Eisai in fulfilling our mission to meet the expectations of the Alzheimer’s disease community. Alzheimer’s disease not only presents a great challenge for patients and their families, but it also negatively impacts society, including decreased productivity, increased social costs and disease-related anxiety. We believe that helping to alleviate these burdens will positively impact society as a whole.
“Additionally, the lecanemab Clarity AD study results prove the amyloid hypothesis, in which the abnormal accumulation of Aβ in the brain is one of the main causes of Alzheimer’s disease, when targeted with a protofibril-binding therapy. 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 .”
Eisai said the next steps are for it to present the findings at an Alzheimer’s conference in late November and follow-up with submission of trial data to the FDA by March. As Eisai has earlier Phase IIb results from 856 patients under its belt, lecanemab is timetabled for accelerated Prescription Drug User Fee Act (PDUFA) approval on 6 January 2023.
“Today’s 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,” said Michel Vounatsos, Chief Executive Officer at Biogen.
“Importantly, the study shows that removal of aggregated amyloid beta in the brain is associated with a slowing of disease in patients at the early stage of the disease … As pioneers in neuroscience, we believe defeating this disease will require multiple approaches and treatment options, and we look forward to continuing the discussion about the significance of these findings with the patient, scientific, and medical communities .”