AstraZeneca and Eli Lilly and Company 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.
“We are saddened by this outcome as our researchers are working tirelessly to find a solution for the many people who are impacted by this devastating disease. We are committed to ensuring our findings can be used to inform further research in the Alzheimer’s community, given the importance of finding a treatment for this disease,” says Menelas Pangalos, Ph.D., Executive Vice President, IMED Biotech Unit, AstraZeneca.
Not based on safety concerns
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.
“The complexity of Alzheimer’s disease poses one of the most difficult medical challenges of our time, and we are deeply disappointed for the millions suffering from this devastating disease,” said Daniel Skovronsky, M.D., Ph.D., president of Lilly Research Labs. “We are grateful for the contributions of the study participants and their families and encourage them to consider other Alzheimer’s disease clinical trials. Lilly remains dedicated to Alzheimer’s disease research as we have been for the last three decades. We won’t give up on finding a solution for Alzheimer’s patients.”
The discontinuation of the lanabecestat Phase III clinical trials in Alzheimer’s disease is not expected to have a material impact on the company’s financial guidance for 2018, which therefore remains unchanged.