AstraZeneca Pharmaceuticals LP issued the following announcement on June 12.
AstraZeneca and Eli Lilly and Company (Lilly) 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.
Menelas Pangalos, Ph.D., Executive Vice President, IMED Biotech Unit, AstraZeneca said: “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.”
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 AMARANTH trial randomised patients with early Alzheimer’s disease to receive lanabecestat, 20mg or 50mg, or placebo orally once daily for 104 weeks. The primary endpoint of the trial was change from baseline on the 13-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13). Early Alzheimer’s disease is defined as the continuum of patients with mild cognitive impairment due to Alzheimer’s disease and patients diagnosed with mild Alzheimer’s disease dementia. Patients who completed the AMARANTH trial were given the opportunity to enrol in the AMARANTH extension trial, where all patients received active treatment.
The DAYBREAK-ALZ trial randomised patients with mild Alzheimer’s disease dementia to receive either lanabecestat, 20mg or 50mg, or placebo orally once daily for 156 weeks. The primary endpoint of the trial was change from baseline on ADAS-Cog13.
Financial considerations
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.
Original source can be found here.
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