Eli Lilly and Company has stopped phase II study (BACC) for LY2886721, a beta secretase (BACE) inhibitor being investigated as a once daily treatment for its potential to slow the progression of Alzheimer's disease. The decision to terminate the study was due to abnormal liver biochemical tests. Clinical study investigators have been notified.
"While stopping this phase II study for our BACE inhibitor is disappointing, patient safety is of utmost importance to Lilly," said Jan M Lundberg, executive vice president, science and technology, and president, Lilly Research Laboratories. "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."
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.
Based on the information Lilly has today, it 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 prior to determining next steps for the entire LY2886721 clinical development programme.
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 currently has eight potential new medicines in its clinical development pipeline being evaluated to treat neuroscience-related diseases and disorders, including: schizophrenia, Alzheimer's disease, depression, bipolar disorder, migraine prevention and osteoarthritis pain. Of the eight potential new medicines, two are currently in Phase III clinical development — edivoxetine and solanezumab.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations.