Crenezumab, a monoclonal antibody (mAb), targets neurotoxic oligomers, a form of beta-amyloid that is associated with the cognitive decline seen in Alzheimer’s disease (AD). The formation of amyloid plaques or small aggregation of beta-amyloid is one theory as to the decline of patients living with AD.
The use of the treatment was aimed at lowering the inflammatory response of the brain in response to the presence of beta-amyloid.
However, in the pre-planned interim analysis, to determine the efficacy and safety of crenezumab, an independent data monitoring committee determined that the mAb was unlikely to meet the primary endpoints of the two Phase III trials.
Sandra Horning, CMO of Roche, said in a statement, “We gratefully acknowledge the participants in the Cread trials and the efforts of everyone involved in this important programme. We remain dedicated to the Alzheimer’s community and will continue our Phase III Graduate trials with gantenerumab and Phase II Tauriel trial with the anti-tau molecule RG6100, as well as our imaging and fluid-based diagnostic solutions.”
Crenezumab will continue to be studied in a trial investigating cognitively healthy individuals who are at risk of developing familial AD.
The therapeutic angle of treating patients who have not yet exhibited signs of AD is being explored more widely across the industry, after a number of high profile failures of drug trials. The clinical push in this direction was acknowledged as worthy of investigation and support by both European and US regulators.
Roche licensed crenezumab from AC Immune in 2006. Shares of AC Immune were down 67% on the news.