AstraZeneca PLC (LON:AZN) and Eli Lilly and Co (NYSE:LLY) have called time on the Phase III trials of their Alzheimer’s drug after interim data suggested it was ineffective at treating the neurodegenerative disease.
Results from the AMARANTH and DAYBREAK-ALZ trials, which were testing lanabecestat on patients with mild Alzheimer’s disease, were not due to be published for another year or so.
Unlikely to meet endpoints
But the two pharma giants said on Tuesday they were stopping the studies on recommendations by an independent data monitoring committee which found that the drug was unlikely to meet its primary endpoints.
“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 AstraZeneca’s executive vice president of innovative medicines and early development, Menelas Pangalos.
“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 decision casts further doubt over BACE inhibitors, a class of Alzheimer’s drugs which many pharma companies had high hopes for.
In theory they work by blocking the formulation and build-up of a protein called amyloid which is often found in the brains of people with the disease.
99% of Alzheimer’s drugs fail
Germany’s Boehringer Ingelheim decided to axe its BACE inhibitor drug shortly before that, too, following another trial failure.
Alzheimer’s is proving a particularly hard nut to crack for Big Pharma: 99% of all drugs designed to treat it have failed clinical trials in the past ten years.
There are currently only four approved drugs which treat the symptoms of the disease which affects tens of millions of people around the world.
“Although clearly disappointing for the field, there were fairly low expectations for the trial with company-compiled consensus containing c.US$200m in risk-adjusted (10%) peak sales,” wrote Shore Capital analyst Tara Raveendran.
“This reflects the difficulties that have been encountered in drug development for Alzheimer’s disease with a number of disappointments to date.”
In early afternoon trading on London, AstraZeneca shares were 0.4% lower at 5,346p, while in pre-market New York trading, Eli Lilley shares were flat at US$85.86.
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