Solanezumab is a monoclonal antibody being developed by Lilly as a potential therapy for people with mild cognitive impairment caused by Alzheimer’s disease (AD), preclinical AD, and dominantly inherited AD.
How solanezumab works
In AD, amyloid proteins clump with each other in the brain and build into plaques possibly blocking cell-to-cell communication, and also activating immune system cells that trigger inflammation. It is an antibody that “cleans” amyloid proteins from the blood and cerebrospinal fluid.
Phase 1 and 2 studies showed a good tolerance and safety profile for Solanezumab in healthy volunteers and in participants with mild to moderate AD.
However, a Phase 3 study in people with AD with mild dementia called EXPEDITION 3 (NCT01900665) did not meet the primary objective, which was the measure of the change from baseline in AD assessment cognitive scale, and has been terminated.
Other Phase 3 studies to assess the continued efficacy and safety in people with AD (NCT01127633) and to investigate the safety and efficacy of solanezumab in people with prodromal AD (NCT02760602) have also been terminated because solanezumab did not meet the primary endpoint like in the EXPEDITION 3 study and there was not enough scientific evidence that solanezumab would likely demonstrate a meaningful benefit to people with prodromal AD.
Although the results of these studies were disappointing, solanezumab continues to be tested in people with a genetic mutation who might be at risk for developing AD (NCT01760005). The estimated study completion date is December 2019.
Another Phase 3 study (NCT02008357) is currently 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 brain amyloids. The estimated study completion date is October 2020.
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