By PETER LOFTUS
Eli Lilly & Co. terminated a midstage clinical trial of an experimental Alzheimer's disease drug after four patients had abnormal liver biochemical tests, the drug maker said Thursday.
It is the latest setback in the hunt by Lilly and other drug companies for a new therapy that can halt or reverse the progression of the neurodegenerative disease, which impairs memory and basic functions primarily in the elderly. Current treatment options can't significantly halt the progress of the fatal disease.
The Lilly drug, code-named LY2886721, was designed to inhibit beta secretase, which contributes to the buildup of amyloid plaque in the brain that is believed to cause Alzheimer's. The drug also is referred to as a BACE inhibitor.
Lilly was comparing different dose levels of the drug with a placebo in a midstage, or phase 2, study. Some 45 patients had received at least one dose of the drug, said Lilly spokeswoman Eva Groves.
The abnormal liver tests were identified during routine monitoring, Lilly said, and the company will continue to monitor the patients. Abnormal liver tests can be a sign of inflammation or damage to the liver.
Lilly doesn't believe the abnormal liver tests are related to the BACE mechanism of action. This suggests that this particular compound had a so-called "off-target" effect that may have contributed to the abnormal liver tests.
"This doesn't appear to be mechanism-related, and therefore we continue to be interested in this mechanism," said Ms. Groves. Lilly doesn't have another BACE inhibitor in clinical testing.
Lilly will evaluate the data from the terminated study to determine the next steps for its BACE inhibitor.
Lilly expects to incur a financial charge for the terminated trial, but it isn't expected to be material and shouldn't change Lilly's 2013 financial guidance.
The halted study is the most recent in a series of Alzheimer's research setbacks for Lilly. In 2010, Lilly stopped development of a different kind of Alzheimer's drug, semagacestat, after studies showed it worsened patients' conditions and was associated with an increased risk of skin cancer.
Last year, Lilly said another drug, solanezumab, didn't meet goals for improving cognition and function in two late-stage studies of patients with mild-to-moderate Alzheimer's disease. Lilly hasn't given up hope on that drug, however, citing an analysis suggesting the drug helped slow cognitive decline in patients with mild Alzheimer's.
Based on that signal, Lilly said it would start another late-stage study of solanezumab in patients with mild Alzheimer's by the end of the third quarter.
Other companies have experienced setbacks in developing new Alzheimer's therapies, including Pfizer Inc., Johnson & Johnson and Baxter International Inc.
Merck & Co. is developing its own BACE inhibitor, MK-8931. The company started a study of the drug last year, and it is expected to run until 2017.
Write to Peter Loftus at peter.loftus@dowjones.com
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