AstraZeneca and Eli Lilly and Company (Lilly) are set to discontinue their Phase III clinical trials of lanabecestat for the treatment of Alzheimer’s disease.
The decision was taken after an independent data monitoring committee (IDMC) concluded that the trials related to lanabecestat were not likely to meet their primary objectives.
The two global trials included the AMARANTH and the DAYBREAK-ALZ trial.
AstraZeneca IMED Biotech Unit executive vice-president 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.
“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.”
Under the AMARANTH trial, patients with early Alzheimer’s disease were randomised to receive 20mg or 50mg of lanabecestat, or placebo orally once daily for 104 weeks.
The trial’s primary objective was change from baseline on the 13-item Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13).
Patients who completed the AMARANTH trial were provided the opportunity to join the AMARANTH extension trial.
However, the IDMC observation has led to the discontinuation of this extension phase.
In the DAYBREAK-ALZ trial, patients with mild Alzheimer’s disease dementia were randomised to receive either lanabecestat at 20mg or 50mg, or placebo orally once-daily for 156 weeks.
Its primary goal was change from baseline on ADAS-Cog13.
Lilly Research Labs president Daniel Skovronsky said: “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.
“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.”
In 2014, AstraZeneca collaborated with Lilly for the development and commercialisation of lanabecestat.
Under the collaboration, Lilly had agreed to lead clinical development and work with researchers from AstraZeneca’s Research and Development Team, while the latter would be responsible for manufacturing of the drug.