Independent data monitoring committee has advised the companies that lanabecestat is unlikely to meet primary endpoints, hence leading to a decision to discontinue these trials.
By Team ABLE
AstraZeneca and Eli Lilly and Company (Lilly) have announced today that the companies are discontinuing the global Phase III clinical trials of lanabecestat, an oral beta secretase cleaving enzyme (BACE) inhibitor, for the treatment of Alzheimer’s disease.
The decision is based on recommendations by an independent data monitoring committee (IDMC), which concluded that both the AMARANTH trial, in early Alzheimer’s disease, and the DAYBREAK-ALZ trial, in mild Alzheimer’s disease dementia, were not likely to meet their primary endpoints upon completion and therefore should be stopped for futility. As a result of this decision, the related AMARANTH extension trial will also be discontinued.
The IDMC recommendation to stop the studies was not based on safety concerns. The AstraZeneca and Lilly BACE alliance for lanabecestat remains in place and the companies will now work with the clinical trial sites involved to implement the discontinuations, reads the statement released by Astra Zeneca.