Eli Lilly announced Friday that it will initiate a Phase III trial of the experimental drug solanezumab in patients with early-stage Alzheimer's disease after the failure last year of studies in those with mild-to-moderate disease. The two previous late-stage studies indicated that the drug did not slow the progression of Alzheimer's disease in patients with mild-to-moderate disease, although further analysis revealed a 34 percent decrease in cognitive decline among those with earlier stages of the condition.
"Since we saw the signal in the mild patients," in the earlier trials, "we're restricting the patient population," remarked Eric Siemers, senior medical director of Eli Lilly's Alzheimer's disease programme. In the Expedition III trial, which will include 2100 patients, the company will use new measures of cognitive function and will also utilise the radioactive imaging agent Amyvid, which was approved by US regulators in 2012, to screen patients for Alzheimer's disease. "The technology wasn't available to test during Expedition I and II, but now we can for every patient going into the trial," said Siemers, adding "it's just better medicine, we have a more accurate diagnosis and a treatment that targets it."
Enrolment in the study is expected to begin before the end of September, and last for around two years, with the final patient visit occurring in late 2016. In the trial, patients will be randomised to receive solanezumab or placebo intravenously every four weeks for 18 months.
In addition to the Expedition III trial, two independent studies to determine whether solanezumab can prevent the development of Alzheimer's disease have been proposed. In the A4 study, researchers plan to determine whether Eli Lilly's drug can prevent the development of Alzheimer's disease in elderly patients with varying levels of beta-amyloid accumulation but no signs of cognitive decline. Results from the trial are expected in 2018. In a second long-term study that was initiated earlier this year, solanezumab is being tested in combination with Roche's gantenerumab to determine whether the drugs can prevent the development of Alzheimer's disease in younger patients with mutations that cause early onset of the disease.
To facilitate the development of drugs for patients with mild Alzheimer's disease, the FDA has proposed relaxing the guidelines for approval of new treatments, indicating that a therapy that slows the progression of disease would be sufficient for approval.
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