AC Immune SA + Genentech initiate a second Phase III trial for crenezumab to treat Alzheimers disease.

AC Immune SA announced that its partner Genentech, a member of Roche group, has decided to start a second Phase III clinical trial of the Alzheimer's therapy crenezumab, an anti-Abeta antibody. This new trial CREAD2 will recruit 750 patients with prodromal or mild Alzheimer's disease. This new trial complements the current Phase III CREAD1 trial of 750 participants with prodromal or mild Alzheimer's disease, expected to read out in 2020.

Trial design details of CREAD2 are not yet available but will be posted on ClinicalTrials.Gov in due course. Crenezumab was discovered by AC Immune using its SupraAntigen technology platform and out-licensed to Genentech in 2006 as a potential therapy for Alzheimer's disease. AC Immune will not receive any milestone payments for the start of this second Phase III trial since the company already received a milestone payment when the CREAD1 trial started.

Comment: Roche presented data from two Phase II studies investigating whether crenezumab can delay cognitive and functional decline in people with mild-to-moderate AD back in 2014, showing that proof-of-concept study failed to meet its primary endpoint. However, the study did demonstrate initial evidence of a crenezumab treatment effect in people with mild AD, and similar effects on clinical decline were observed in BLAZE, a smaller biomarker study.