Genentech plans second Phase 3 Alzheimer's trial following endpoint failures
Genentech, Roche’s biotech group, has announced its plans to conduct a second Phase 3 study for crenezumab, its anti-Abeta antibody for the treatment of early Alzheimer’s disease.
The trial is designed to further elucidate earlier traces data on the drug’s efficacy in treating Alzheimer’s; crenezumab failed to meet its primary endpoint of slowing cognitive degeneration in mild-to-moderate forms of the disease in two 2014 Phase 2 studies, but did show promise as a treatment in the earliest stages.
The new CREAD2 study will incorporate 750 participants with prodromal or mild Alzheimer’s disease and will function as complimentary to the current CREAD1 Phase 3 study. Both will assess the effects of the humanised IgG4 monoclonal antibody in treating the disease by binding misfolded amyloid beta proteins which are thought to be a leading cause of Alzheimer’s development.
Crenezumab was originally discovered by AC Immune. Chief Executive Andrea Pfeifer commented: "Given the recent disappointing results of other therapies, all of us in the Alzheimer's community need to redouble our efforts to combat one of society's biggest challenges. We remain confident about the potential of crenezumab given it is distinct from other beta amyloid antibodies, predominantly blocking oligomers in the brain, and has a clinical development program that is using higher dosing and targeting earlier stages of Alzheimer's disease."
It is thought that the drug could generate over $4 billion in sales by 2028.