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Delaying the progression to Alzheimer’s dementia

A HOLD FreeRelease 5

BioArctic AB’s partner Eisai announced today that an article about long-term health outcomes of the investigational anti-amyloid-beta (Aβ) protofibril antibody lecanemab (BAN2401) in people living with early Alzheimer’s disease (AD), using disease modeling, was published in the peer-reviewed journal Neurology and Therapy. In this simulation, lecanemab treatment is estimated to slow the rate of disease progression, maintaining treated patients for a longer duration in earlier stages of the disease.

The article focuses on the long-term clinical outcomes for people living with early AD (mild cognitive impairment (MCI) and mild AD) who have amyloid pathology, comparing lecanemab together with standard of care (SoC) versus SoC alone (acetylcholinesterase inhibitor or memantine). The simulation is based on patients being treated until they reach the moderate AD stage. The disease simulation model (AD ACE model1) is based on the results of the Phase 2b clinical trial evaluating the efficacy and safety of lecanemab, and from ADNI (Alzheimer’s Disease Neuroimaging Initiative) study results.

Lecanemab treatment was estimated to slow the rate of disease progression, resulting in an extended duration of MCI due to AD and mild AD dementia and shortened the duration in moderate and severe AD dementia. In the model the mean time advancing to mild, moderate, and severe AD dementia was longer for patients in the lecanemab-treated group than for patients in the SoC group by 2.51 years, 3.13 and 2.34, respectively. The model also predicted a lower life-time probability of admission to institutional care with lecanemab treatment.

“The results from the simulation done by Eisai demonstrate the potential clinical value of lecanemab for patients with early AD and how it could slow the rate of disease progression, delay progression to AD dementia with several years and reduce the need for institutionalized care. Analyses such as these are important to understand the potential long-term effects for patient, families and society offered by lecanemab treatment beyond what can be seen in clinical trials. The outcome of the Clarity AD Phase 3 study will be essential to further refining this model, and we are looking forward to the topline results later this year,” said Gunilla Osswald, BioArctic’s CEO.

Lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. Eisai anticipates completing lecanemab’s rolling submission of a Biologics License Application for the treatment of early AD to the FDA under the accelerated approval pathway in the second quarter 2022. Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial is expected by end of September 2022. Eisai initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data of lecanemab under the prior assessment consultation system in Japan in March 2022.

This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

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