Jan M. Lundberg, executive vice president for science and technology and president of Lilly Research Laboratories, said 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, Lundberg said.
"While stopping this Phase II study for our beta secretase inhibitor is disappointing, patient safety is of utmost importance to Lilly," Lundberg said in a statement. "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."
Lundberg said the abnormal liver biochemical tests observed in the study were not related to the beta secretase mechanism. The pharmaceutical giant said it is still interested in developing beta secretase inhibitors for the benefit of patients with Alzheimer's disease.
Lilly will further evaluate this data prior to determining next steps for the entire Phase II study beta secretase for LY2886721 clinical development program, Lundberg said.
The company expects to incur a financial charge associated with the decision to stop this trial. However, the amount of this charge is not expected to be material and is not expected to result in a change to the company's previously-issued 2013 financial guidance, Lilly said.
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