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AstraZeneca, Eli Lilly terminate clinical trials of Alzheimer's disease treatment lanabecestat

PBR Staff Writer Published 12 June 2018

AstraZeneca and Eli Lilly have announced the termination of global phase 3 clinical trials of Alzheimer's disease treatment, lanabecestat, which is an oral beta secretase cleaving enzyme (BACE) inhibitor.

An independent data monitoring committee (IDMC) has recommended the partnership to stop the trials of lanabecestat, as it is unlikely to meet primary endpoints.

AstraZeneca IMED biotech unit executive vice president Dr Menelas Pangalos 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.”

Both firms are discontinuing Amaranth trial, in early Alzheimer's disease, and the Daybreak-Alz trial, in mild Alzheimer's disease dementia, which are unlikely to meet their primary endpoints upon completion.

In Amaranth trial, the patients with early Alzheimer's disease have been randomized to secure lanabecestat 20mg or 50mg, or placebo orally once daily for 104 weeks.

The primary endpoint of the study was change from baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13).

In Daybreak-Alz trial, the patients with Alzheimer's disease dementia were andomized to receive lanabecestat 20mg or 50mg, or placebo orally once daily for up to 156 weeks.

The primary endpoint of the study was change from baseline on ADAS-Cog13.

In 2014, AstraZeneca collaborated with Lilly to develop and commercialize lanabecestat.

Under the deal, Lilly assumed the responsibility of lanabecestat’s clinical development through taking the support of AstraZeneca's Research and Development Team, while AstraZenec assumed the responsibility for manufacturing.

Lilly Research Labs president Dr Daniel Skovronsky said: "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."