Eli Lilly and Co. (LLY) Thursday said it has stopped its Phase II study for LY2886721, a beta secretase or BACE inhibitor being investigated as a once daily treatment for its potential to slow the progression of Alzheimer's disease, due to abnormal liver biochemical tests.
The cases of abnormal liver biochemical tests were identified as part of routine monitoring. Lilly will continue to monitor all participants with abnormal liver biochemical tests. Clinical study investigators have been notified, Lilly noted.
The company expects to incur a charge associated with the decision to stop this trial. However, it is not expected to be material and is not expected to result in a change to the company's financial guidance for 2013.
Based on the information it has so far, Lilly believes that the abnormal liver biochemical tests observed in this study are not related to the BACE mechanism and continues to be interested in developing BACE inhibitors for the benefit of patients with Alzheimer's disease.
Lilly will further evaluate this data before determining next steps for the entire LY2886721 clinical development program.
Jan Lundberg, executive vice president, science and technology, and president, Lilly Research Laboratories, said, "While stopping this Phase II study for our BACE inhibitor is disappointing, patient safety is of utmost importance to Lilly."
LLY closed marginally higher on Thursday at $51.85 and slid 1.1 percent in the extended trade.
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