Lilly Terminates Phase II Study of Alzheimer's Drug Due to Abnormal Liver Biochemical Tests

Eli Lilly has discontinued its Phase II study of the beta secretase (BACE) inhibitor, LY2886721, as a treatment for Alzheimer's disease. The decision was due to abnormal liver biochemical tests identified during routine monitoring.
Jun 13, 2013
By PharmTech Editors

Eli Lilly announced it has discontinued its Phase II study, which investigated the company’s beta secretase (BACE) inhibitor, LY2886721, as a once-daily treatment for slowing the progression of Alzheimer’s disease. The decision to terminate the study was because of abnormal liver biochemical tests identified during routine monitoring. Clinical study investigators have been notified and Lilly will continue to monitor all participants with abnormal liver biochemical tests.

"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 in a press release. "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."

Lilly believes that the abnormal liver biochemical tests observed in this study are not related to the BACE mechanism and will continue development of other BACE inhibitors for Alzheimer’s disease. Data will be evaluated before the company determines next steps for the LY2886721 clinical development program.

The company expects to incur a financial charge as a result of terminating this trial. However, the amount of this charge is not expected to change the company's previously-issued 2013 financial guidance.