Eli Lilly (NYSE: LLY) and AstraZeneca are discontinuing the global Phase 3 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 Lilly and Astrazeneca BACE Alliance for lanabecestat remains in place, and the companies will now work with the clinical trial sites involved to implement the discontinuations.
"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," said Menelas Pangalos, Ph.D., Executive Vice President, IMED Biotech Unit, AstraZeneca. "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."
Last month Johnson and Johnson abandoned development of a similar Alzheimer's candidate. Lilly has previously discontinued development on another BACE candidate. Roche and Merck have also failed to advance candidates in the class.
The long string of failures in the efforts to develop drugs that halt the progression have caused some companies to abandon the pursuit. However Lilly says they will continue to search for an effective treatment, “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," said Daniel Skovronsky, M.D., Ph.D., president of Lilly Research Labs.