LONDON, 13 Sep (APM) - Eisai and partner Biogen said on Friday that they are dropping development of elenbecestat in patients with early Alzheimer's disease due to an unfavourable risk-benefit ratio.
The decision to discontinue the trials was based on the results of a safety review conducted by the data safety monitoring board, said Eisai in a statement
In addition, the long-term extension of the Phase II clinical trial of elenbecestat will also come to a halt despite earlier results demonstrating that the drug was generally safe, well-tolerated and reduced beta-amyloid in the brain in patients with mild cognitive impairment or mild to moderate Alzheimer's (APMHE 58419
Lynn Kramer, chief clinical officer, Eisai, said: "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."
The drug, which is an investigational oral beta amyloid cleaving enzyme inhibitor, becomes the latest in a string of late-stage failures for Alzheimer's, with several companies including Roche, Merck & Co and Pfizer previously admitting defeat with their candidates (APMHE 61634
, APMHE 56870
, APMHE 56320
Eisai and Biogen, which were jointly developing three experimental drugs all targeting the brain-destroying protein beta-amyloid for Alzheimer's, also had a setback with another candidate known as aducanumab earlier this year.
The companies said they had to end the Phase III trials for that drug after an independent data monitoring committee concluded that the studies were unlikely to meet their primary endpoint (APMHE 62348
However, the latest decision will not impact the development of the companies' third and final Alzheimer's partnered drug BAN2401, an anti-amyloid beta protofibril monoclonal antibody.
Eisai said it will still continue to run the Phase III CLARITY AD trial despite the candidate being met with much scepticism since the partners reported promising but confusing 18-month results in July 2018 (APMHE 59070