Roche Discontinues Phase III Trial of Gantenerumab

Roche has announced the decision to discontinue SCarlet RoAD (WN25203), a Phase III study of investigational anti-amyloid medicine SCarlet RoAD in prodromal (pre-dementia) Alzheimer’s disease, based on results of a pre-planned futility analysis and recommendation by the independent Data Monitoring Committee. No new safety signals for gantenerumab were observed in this analysis and the overall safety profile was similar to that seen in the Phase I trial (NN19866).

Data from the SCarlet RoAD study will be shared with the medical community after full review and analysis. Findings from the trial will inform future research programmes, approaches and clinical trial design.

“We are disappointed with these study results because people with early stage Alzheimer's need new medicines that delay disease progression,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Roche. “This is the first Phase III trial to evaluate a potential disease-modifying medicine in this early prodromal stage of Alzheimer’s disease. We remain committed to investigating new medicines for this devastating illness.”

Alzheimer’s disease is a major focus of Roche neuroscience research and development. The company has a broad research programme that focuses on several pathways believed to play important roles in Alzheimer’s disease. Its researchers are developing and investigating medicines designed to target these pathways in multiple ways and across different stages of the disease. Gantenerumab continues to be evaluated in the phase III Marguerite RoAD study (WN28745) in a later stage of Alzheimer’s disease (mild dementia due to Alzheimer’s). In addition, Roche has two investigational medicines for the disease in phase II development (crenezumab, an anti-amyloid antibody, and RG1577, a monoamine oxidase-B inhibitor).