Eli Lilly announced Thursday that it halted its Phase II study for the experimental beta secretase (BACE) inhibitor, LY2886721, due to abnormal liver biochemical tests. The company said that based on the information it received, it believes the abnormal tests, which were identified as part of routine monitoring, "are not related to the BACE mechanism," and that it "continues to be interested in developing BACE inhibitors for the benefit of patients with Alzheimer's disease."
The drugmaker said it will continue to monitor all study participants with abnormal liver biochemical tests, in addition to further evaluating the data, in order to decide the next steps for the entire LY2886721 clinical development programme. Eli Lilly also specified that the decision does not impact other Alzheimer's disease compounds it has in development. In December 2012, the company stated it would conduct an additional late-stage study of the monoclonal antibody solanezumab in patients with mild Alzheimer's disease.
Eli Lilly indicated that while it expects to incur a financial charge associated with the decision to halt the LY2886721 trial, the amount is unlikely to cause it to change its guidance for the year.
Merck & Co. is also developing a BACE inhibitor, dubbed MK-8931, for which it entered into a collaboration with Luminex earlier this year. Merck's drug is currently in Phase II/III testing in the EPOCH trial for patients with mild-to-moderate Alzheimer's disease.
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