- Two phase II studies in people with mild-to-moderate Alzheimer’s disease over 18 months and a total of 522 patients
- The proof of concept ABBY study met overall objective of estimating treatment effects and demonstrated positive trends in cognitive endpoints over time, although the study did not meet its co-primary endpoints
- Larger effects seen in patients with mild disease on high-dose of crenezumab intravenously
- Acceptable risk benefit profile
- Next steps to be determined by Roche following further analysis of data
Lausanne, Switzerland, – July 16, 2014 – AC Immune today announced the presentation of data from two phase II studies investigating whether crenezumab (anti beta-amyloid antibody) can delay cognitive and functional decline in people with mild-to-moderate Alzheimer’s disease (AD) by its partner Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY). The larger proof of concept study, known as ABBY, showed differences from placebo favoring crenezumab in the rate of cognitive decline, especially in milder patients. Similar effects of favoring crenezumab in milder patients were observed in BLAZE, a smaller biomarker study. Although generally not reaching statistical significance, changes in both studies were consistent over time, providing evidence for a beneficial effect of crenezumab in people with mild AD. The findings were presented at the Alzheimer’s Association International Conference (AAIC) 2014 in Copenhagen, Denmark. Roche will determine next steps for crenezumab after further analysis of the data.