Eli Lilly announced Friday that two Phase III trials of the experimental drug solanezumab in patients with mild-to-moderate Alzheimer's disease failed to meet their main cognitive and functional goals. However, the company noted that a "significant slowing of cognitive decline" was seen across both studies in patients with mild disease, a finding that wasn't expected by analysts, who had given the drug less than a 20 percent chance of showing such a benefit.
"We recognise that the solanezumab studies did not meet their primary endpoints, but we are encouraged by the pooled data that appear to show a slowing of cognitive decline," remarked CEO John C. Lechleiter. Jan Lundberg, president of Lilly Research Laboratories, added that "we believe the pooled data support the amyloid hypothesis, as these are the first Phase III data with an anti-beta amyloid agent that appear to show a slowing of cognitive decline."
The EXPEDITION1 and EXPEDITION2 studies, which ran for 18 months, included more than 2050 patients with mild-to-moderate Alzheimer's disease. Eli Lilly noted that although the EXPEDITION1 trial missed its co-primary endpoints in the overall patient population, pre-specified secondary subgroup analyses in those with mild Alzheimer's disease showed a significant reduction in cognitive decline. According to the company, the statistical analysis plan for EXPEDITION2 was amended prior to database lock to specify a single primary endpoint of cognition in the mild patient population. However, the drugmaker noted that the revised goal did not achieve statistical significance.
Lechleiter said that Eli Lilly will "discuss these data with regulatory authorities to gain their insights on potential next steps," which have not yet been decided. Mike Krensavage, founder of Krensavage Asset Management, noted that "people expected nothing, and instead we have some hints of efficacy," adding that "the right thing now is probably to do another trial." Bernstein Research analyst Tim Anderson said it was possible that the company could apply for FDA approval based on the data, although he suggested that it was more likely that additional studies would have to be completed first. Meanwhile, ISI Group analyst Mark Schoenebaum said the chances of regulatory approval of solanezumab increased to a range of 20 percent to 30 percent from 10 percent because of the new data.
Earlier this month, Pfizer and Johnson & Johnson indicated that they will discontinue clinical trials of their similar drug bapineuzumab in patients with mild-to-moderate Alzheimer’s disease after the agent failed to meet the co-primary endpoints of two Phase III studies.
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