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Data suggests Lilly’s solanezumab slows progression of mild Alzheimer’s
22 July 2015 • Author: Victoria White
Lilly has announced results suggesting that solanezumab slows the progression of Alzheimer’s in patients with mild disease.
Solanezumab is Lilly’s Phase 3 monoclonal antibody being studied as a potential therapy for patients with mild Alzheimer’s disease. Solanezumab binds to soluble monomeric forms of amyloid-beta after it is produced, allowing it to be cleared before it clumps together to form beta-amyloid plaques.
The treatment effect of solanezumab was preserved within a pre-specified amount in patients with mild Alzheimer’s disease who received solanezumab earlier in the disease compared to patients who began treatment at a later point.
These results were from a pre-specified secondary analysis of three Phase 3 studies (EXPEDITION, EXPEDITION2 and EXPEDITION-EXT) and support the use of the “delayed-start” method for assessing the potential effects of a treatment on the underlying disease progression of Alzheimer’s disease.
“We are particularly excited about these data because this is the first time the delayed-start methodology has been implemented for an Alzheimer’s disease clinical trial,” said Hong Liu-Seifert, Ph.D., study research advisor at Eli Lilly and Company. “This new analytical method enabled us to assess if solanezumab had an effect that is consistent with slowing progression of disease by modifying the underlying disease progression, which, up until now, has not been studied. These results support the trial design and delayed-start analysis plan of EXPEDITION3, which is expected to have the last patient visit in October 2016.”
Treatment differences in cognition and function between early-start and delayed-start groups were preserved
The objective of the delayed-start analysis was to assess a possible disease-modifying effect of solanezumab in patients with mild Alzheimer’s disease. These results were obtained from a pre-specified secondary analysis of the Phase 3 EXPEDITION, EXPEDITION2 and EXPEDITION-EXT studies. EXPEDITION and EXPEDITION2 had identical study protocols, which included an 18-month randomized, double-blind, placebo-controlled period, after which a two-year delayed-start period occurred (EXPEDITION-EXT), where the placebo-treated patients from the placebo-controlled period began treatment with solanezumab.
Key results from the studies showed that treatment differences in cognition and function between early-start and delayed-start groups at the end of the placebo-controlled period (80 weeks since randomization) were preserved at the primary time point of 108 weeks (28 weeks after the start of EXPEDITION-EXT) within a pre-defined margin. This difference at 108 weeks remained statistically significant. Also, treatment differences in cognition and function between early-start and delayed-start groups at the end of the placebo-controlled period (80 weeks since randomization) were also preserved at an additional time point of 132 weeks (52 weeks after the start of EXPEDITION-EXT) within a pre-defined margin. This difference at 132 weeks was statistically significant.
Commenting on the results, Alzheimer’s Society’s Head of Research, Dr Doug Brown said, “It’s good news that some people have been receiving the antibody for over three years and it appears to be having beneficial effects. The current trial has finished recruiting participants, so in just 18 months we may get an exciting first look at the final results.”
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