Eli Lilly & Co. said it stopped a mid-stage trial of an experimental Alzheimer’s drug designed to mimic the effect of a rare genetic mutation that may protect against the disease.
The trial of LY2886721 ended after participants showed abnormal liver biochemistry, Lilly said today in a statement. The drug was in the second of three phases of clinical trials typically required before regulatory approval and was being tested in about 150 patients. Lilly said it plans to take an undisclosed financial charge that won’t affect 2013 guidance.
“Lilly will further evaluate this data prior to determining next steps for the entire LY2886721 clinical development program,” the Indianapolis-based company said.
The drug was in a category called beta secretase, or BACE, inhibitors. Merck & Co. is developing a drug in the same class. The therapies help prevent the formation of plaque tangles in the brain called beta amyloid, which is associated with Alzheimer’s.
The mechanism differs from that of a failed experimental therapy from Johnson & Johnson and Pfizer Inc., and one from Lilly that is still in development. Those drugs are designed to clear beta amyloid from the brain by binding directly to the protein.
Lilly said it didn’t think the abnormal liver results were a broad effect of BACE inhibitors as a class and plans to continue looking at the mechanism as an Alzheimer’s treatment. The company has informed doctors running the trial.
More than 5 million Americans have Alzheimer’s, according to the Alzheimer’s Association, a disease advocacy group. The neurodegenerative disease is the sixth-leading cause of death in the U.S., according to the association’s website. There is no approved cure for Alzheimer’s on the market.