Eli Lilly[3] & Co. has made changes in the way it tests an experimental drug for Alzheimer's disease, aimed at improving the drug's chances of succeeding in a new clinical trial after it failed to hit key goals in prior studies.
The Indianapolis drug maker will begin shortly a 2,100-patient clinical trial—expected to take years to complete—that will only enroll patients with a mild form of the dementia-causing disease, whereas prior studies also enrolled patients at a more advanced stage of the disease. Some scientists think treating earlier-stage patients may improve outcomes.
Also, Lilly researchers only will enroll patients with signs of a protein in their brains called amyloid—which is believed to be a culprit of Alzheimer's and is a target of Lilly's drug—as measured by imaging and lab tests. Prior studies had broader inclusion criteria.
The changes "may allow us to identify patients most likely to benefit" from the drug, solanezumab, Eric Siemers, senior medical director of Lilly's Alzheimer's research team, said Friday on a conference call with analysts and reporters.
But success isn't guaranteed, and there remains some uncertainty that targeting amyloid is the best approach to fighting Alzheimer's. Other amyloid-fighting drugs have failed in clinical studies, including some developed by Lilly, Pfizer[4] Inc. and Johnson & Johnson[5] . Some scientists have suggested that targeting other biological pathways could better combat Alzheimer's.
In Lilly's case, the answer may not come for several years. The new screening standard means Lilly will have to screen more patients to find the 2,100 eligible study participants.
Enrollment is expected to take nearly two years, with the last patient visit seen in late 2016. That implies potential regulatory action late in the decade, if the trial is successful and if Lilly applies for approval to market the drug.
About half of the patients will receive solanezumab, which is infused intravenously, and half will get a placebo every four weeks, over a treatment period of about 18 months.
Alzheimer's disease is a brain disorder that impairs memory and other cognitive skills as well as the ability to perform activities of daily living. More than five million primarily elderly Americans are believed to have the disease, according to the Alzheimer's Association.
Current treatments can temporarily help symptoms but don't stop the worsening of the underlying disease. Lilly and other drug makers are seeking a new drug that would halt or reverse the progression of Alzheimer's.
Last year, Lilly released results of two late-stage clinical trials, showing the drug failed to meet primary efficacy goals for cognition and function in each study. But Lilly said pooled results from both studies suggested a benefit in patients with a mild form of the disease.
Analysts believe a multibillion-dollar market awaits the first drug that can halt or reverse the underlying disease.
Write to Peter Loftus at peter.loftus@dowjones.com[6]
References
- ^ PETER LOFTUS (topics.wsj.com)
- ^ CONNECT (online.wsj.com)
- ^ Eli Lilly (online.wsj.com)
- ^ Pfizer (online.wsj.com)
- ^ Johnson & Johnson (online.wsj.com)
- ^ peter.loftus@dowjones.com (online.wsj.com)
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