Roche halts its Phase III CREAD1 and CREAD2 studies of AD drug crenezumab

30/01/2019

On 30 January, the Swiss multinational biotech company Roche announced that it has decided to discontinue its CREAD1 and CREAD2 Phase III studies of the investigational anti-beta-amyloid drug crenezumab in early Alzheimer’s disease (AD).

CREAD1 and 2 are multicentre, randomised, double-blind, placebo-controlled and parallel-group Phase III studies evaluating the efficacy and safety of crenezumab in 1,500 people worldwide with prodromal to mild AD. CREAD1 started in early 2016 and CREAD2 in mid-2017.

Studies will be discontinued based on the results from a pre-planned interim analysis. An independent data monitoring committee reported that crenezumab was not expected to meet its primary endpoint of change in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score. Data will be presented at upcoming conferences.

Crenezumab continues to be investigated in the Alzheimer’s Prevention Initiative (API) study. Roche will also continue its GRADUATE Phase III trial with gantenerumab and the TAURIEL Phase II trial with RG6100 for the treatment of AD.

https://www.roche.com/media/releases/med-cor-2019-01-30.htm