Lilly Plans A Bigger Study – And Bet – For Its Alzheimer’s Drug

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Seven months after promising to start another Phase III trial of its solanezumab compound for Alzheimer’s in patients with a mild form of the disease, Eli took the unusual step of holding a teleconference to disclose details about the design of the forthcoming , which is set to begin in the third quarter.

To be called Expedition 3, the trial is a gamble by Lilly to justify ongoing investment in the risky field of Alzheimer’s development. Last year, the drugmaker released results of two other Phase III trials – Expedition 1 and 2 – that failed to show statistical significance. Now, Lilly hopes a greater emphasis on patients with mild Alzheimer’s will pay off, although results will not be known for three years and the drugmaker is declining to say how much this will cost.

When Lilly disclosed results from the previous trials, which tested solznezumab in patients with both mild and moderate forms of Alzheimer’s, the drugmaker noted cognitive decline was slowed by 42 percent in patients in the early stages in one trial and there were also positive signs from another trial. Just the same, this was a case of ‘close, but not close enough’ (back story).

However, a pre-specified secondary analysis of pooled data yielded a 34 percent reduction in cognitive decline in patients with mild Alzheimer’s, which was statistically significant. While the overall showing was mixed, the results underscored a belief, at least among Lilly execs, that the compound may prove successful at combating symptoms in some early-stage Alzheimer’s patients (back story).

The trial will test 2,100 patients, a sample size that is about 60 percent greater than the two earlier trials and patients will receive the same 400mg dosing per month that took place in those trials, which suggests Lilly…Read more

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