Crenezumab from AC Immune is an investigational therapy. It is an antibody that binds to amyloid-beta proteins to prevent and break up their aggregation in existing plaques in Alzheimer’s disease. The aggregation and accumulation of amyloid-beta proteins in the brain are the hallmarks of Alzheimer’s.

How crenezumab works

Crenezumab is a monoclonal antibody designed to reduce the effector function of microglia and to clear amyloid-beta from the brain, reducing inflammation. Microglia are the immune cells of the central nervous system derived from bone marrow. They have an important role in brain inflammation.

Crenezumab can recognize different forms of amyloid-beta aggregates and plaques. It stimulates the cellular ingestion of amyloid plaques and limits the release of cell signaling molecules (cytokines) that promote inflammation.

Crenezumab in clinical trials

Phase 1 studies in healthy volunteers and people with Alzheimer’s showed crenezumab to be safe, leading to Phase 2 studies (ABBY,  NCT01343966) and (BLAZE, NCT01397578) that used higher doses and achieved higher brain exposure than in the Phase 1 studies. Completed in 2014, these studies continued into an open-label extension study (NCT01723826) that is assessing the long-term safety profile in people with Alzheimer’s disease who had participated in former studies.

A positive trend in reduction in functional decline was observed in the brains of patients as measured by PET scans (positron emission tomography)suggesting a reduction of amyloid accumulation.

Following these results, crenezumab moved into Phase 3 clinical development in people with prodromal to mild Alzheimer’s (the CREAD study, NCT02670083) evaluating the effectiveness and safety of an intravenous infusion of crenezumab compared to placebo. Participants receive the infusion every four weeks for 100 weeks, with the final assessment performed 52 weeks after the last dose.

AC Immune’s partner Genentech recently announced it would initiate a second Phase 3 study called CREAD2.

Another Phase 2 study (NCT01998841) is currently ongoing in pre-symptomatic participants from an extended Columbian family where 200 members carry a mutation known to cause early onset of Alzheimer’s.

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