Solanezumab (formerly known as LY2062430) is a monoclonal antibody being developed by Lilly as a potential therapy for people with mild cognitive impairment caused by Alzheimer’s disease.
How solanezumab works
In Alzheimer’s disease, protein deposits called amyloids can group together in the brain and build into plaques, possibly blocking cell-to-cell communication and activating immune system cells that trigger inflammation. Solanezumab is an antibody that aims to “clean” amyloid proteins from the blood and cerebrospinal fluid in an effort to prevent plaque formation.
Solanezumab in clinical trials
Phase 1 and 2 studies showed a good tolerance and safety profile for solanezumab in healthy volunteers and in patients with mild to moderate Alzheimer’s disease.
However, a Phase 3 study (NCT01900665) called EXPEDITION 3 in 2,129 people with Alzheimer’s-associated mild dementia did not meet the primary objective, which was the measure of the change from baseline in Alzheimer’s disease assessment scale-cognitive 14 item subscore (ADAS-Cog14), and was terminated. The results of the study were published in the New England Journal of Medicine.
Two other Phase 3 studies (NCT01127633 and NCT02760602) to assess the continued efficacy and safety of solanezumab in people with Alzheimer’s disease have also been terminated because of the failure of the EXPEDITION 3 study.
Although the results of these studies were disappointing, solanezumab is still being tested in people with a genetic mutation that might put them at risk for developing Alzheimer’s disease in a Phase 2/3 clinical trial (NCT01760005) called DIAN-TU. In the study, solanezumab and gantenerumab, another investigational therapy for Alzheimer’s disease, will each be tested against placebo to see whether they can reduce the rate of decline in patients. The study is expected to be completed in December 2020.
Another Phase 3 study (NCT02008357) called A4 is recruiting participants who do not have memory loss but have evidence of amyloid beta buildup in the brain. This study aims to assess whether solanezumab can slow the progression of memory problems associated with amyloids. The estimated completion date of this study is July 2022.Â
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