It's not been a good couple of years for Alzheimer's research. Recently, Baxter's Gammagard joined J&J and Pfizer's iv bapineuzumab and Eli Lilly's solanezumab in a list of late-stage failures. Now, Lilly has voluntarily stopped a phase II trial of another of its Alzheimer's disease drug candidates. This time, it was the company's beta secretase 1 (BACE-1) inhibitor, LY2886721, that was given the axe.
Through inhibition of beta secretase, BACE inhibitors can theoretically prevent the production of beta amyloid. However, rather than the drug not being effective, Lilly say the decision to terminate the study was on the basis of abnormal liver biochemical tests. Perhaps the good news is that Lilly don't believe that the abnormal liver tests were related to the BACE mechanism, and they retain interest in developing BACE inhibitors in the future. The company say they will further evaluate the data before deciding on their next steps with the drug.
“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. “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.”
Eyes will now be on the results of clinical trials with other BACE inhibitors, including Merck's MK-8931, AstraZeneca's AZD3293, Roche's RG7129, and Eisai's E2609.
The trial was halted at Phase II rather than at Phase III, which would have been much more costly for the company. If you want to know more about the detection, analysis and prevention of adverse drug reactions with case studies, industry experiences and global regulatory coverage of developments, you might be interested in attending the World Drug Safety Congress Europe 2013, 10-12 September 2013, London.
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