Alzheimer's Disease Drug Stopped Mid-Trial
June 17, 2013

Eli Lilly & Co Halts Alzheimer’s Drug Trial

Lee Rannals for - Your Universe Online

Eli Lilly & Co has ended a clinical trial for an Alzheimer's disease drug during the middle of the study after patients showed abnormal liver biochemical tests.

The company announced last week that it would be putting a halt to its LY2886721 drug trial. LY2886721, the code-name for the drug, was designed to inhibit beta secretase, which contributes to the buildup of amyloid plaque in the brain that is believed to cause Alzheimer's.

During the mid-stage clinical trial, the company was comparing different dose levels of the drug with a placebo on 45 patients. Abnormal liver tests were identified during routine monitoring, which could be a sign of inflammation or damage to the liver. Lilly said it would be continuing to monitor the patients.

"While stopping this Phase II study for our BACE inhibitor is disappointing, patient safety is of utmost importance to Lilly," said Jan M. Lundberg, Ph.D., executive vice president, science and technology, and president, Lilly Research Laboratories. "Discovering and developing medicines for devastating diseases like Alzheimer's is fraught with many challenges, but Lilly's 25-year commitment to bringing medicines to the millions of Alzheimer's disease patients who are waiting will not wane."

The company said it doesn't believe the abnormal tests are related to the BACE mechanism, which suggests this particular compound effect may have contributed to the abnormal liver tests. Lilly said it would further evaluate this data in order to determine the next steps for the entire LY2886721 clinical development program.

Nearly 7.7 million new cases of dementia are reported each year, which is the equivalent of a new case every four-seconds. Lilly said between two and 10 percent of all cases of dementia start before the age of 65-years-old. The worldwide cost of Alzheimer's was $604 billion in 2010.

Although the trial for LY2886721 has ended, there is still plenty of promising research being done for Alzheimer's disease. Scientists at Washington University School of Medicine in St. Louis wrote in the journal Science Translational Medicine about how they identified a pivotal difference between the brains of patients with an inherited Alzheimer's disease and healthy family members. Understanding these differences will help lead to new treatments for inherited Alzheimer's disease as well as lay ground work for potential research into the common sporadic forms of the disease.

“We hope that our new insights about the production and clearance of amyloid beta proteins will pave the way for future studies aimed at understanding and altering the metabolic processes that underlie this devastating disease,” said metabolism expert Bruce Patterson.