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Biogen and Eisai drop Alzheimer’s drug elenbecestat

Latest blow in string of failures for BACE inhibitor category


In a potential final blow to the BACE inhibitor treatment category, Biogen and Eisai have discontinued trials of elenbecestat after the Data Safety Monitory Board suggested the drug had an “unfavourable risk-benefit ratio”. 

The failure of elenbecestat comes on the heels of Amgen and Novartis also abandoning phase 2/3 studies of BACE1 inhibitor CNP520 (umibecestat) after some participants taking the drug saw their condition deteriorate faster than those on the placebo arm.

The sadly predictable pattern of the BACE inhibitor category is taking a familiar shape, with candidates being routinely abandoned in the late research stages.

Merck & Co/MSD, Janssen and Eli Lilly have all reported similar patterns in earlier failed candidates in the category.

BACE inhibitor drugs target the beta amyloid cleaving enzyme (BACE), which plays a key role in the production of beta amyloid (Aβ) peptides. The aim has been to reduce the production of Aβ peptides, which in turn would reduce amyloid plaque formations in the brain and slow the progression of Alzheimer’s.

Lynn Kramer

Lynn Kramer, chief clinical officer, Neurology Business Group, Eisai

“We are very disappointed with the news, and intend to learn from these data and continue engaging with patients and investigators, to pursue the discovery of new medicines for Alzheimer's disease," said Lynn Kramer (pictured above).

Elenbecestat was being studied in two pivotal phase 3 studies in patients with early Alzheimer’s disease, and in an additional phase 2 study. By abandoning elenbecestat, the two pharma companies now have only one amyloid-targeting drug left in the pipeline– a phase 3 study of amyloid-targeting candidate BAN2401, which remains unaffected by the discontinuation, with results set to read out in 2022.

BAN2401 was shown to reduce disease progression by a third at the highest dose in a phase 2 trial last year. However, there was concern that patients on lower dose of the drug seemed to decline more quickly than those on the placebo arm.

Biogen and Eisai also had to pull the plug on their phase 3 Alzheimer’s candidate aducanumab earlier this year. The antibody, which targeted soluble amyloid, had been due for its phase 3 read out in 2020.

These continuing late-stage failures strengthen the sentiment that the ‘amyloid hypothesis’ of targeting beta amyloid has now been all-but exhausted. This is being reflected in a growing pipeline of early stage candidates that are targeting other mechanisms of the disease.

Article by
Lucy Parsons

16th September 2019

From: Research



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