Roche decided to discontinue SCarlet RoAD, a Phase III study of gantenerumab in prodromal (pre-dementia) Alzheimer’s disease, based on results of a preplanned 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.

Data from the SCarlet RoAD study will be shared with the medical community after full review and analysis, according to a Roche spokesperson, who added that findings from the trial will inform future research programs, 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, M.D., 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.”

Gantenerumab, a fully human, monoclonal antibody developed and designed by MorphoSys to decrease levels of beta amyloid, continues to be evaluated in the Phase III Marguerite RoAD study in a later stage of Alzheimer’s disease (mild dementia due to Alzheimer’s). In addition, Roche has two other candidates in Phase II development (crenezumab, an anti-amyloid antibody, and RG1577, a monoamine oxidase-B inhibitor).

“The discontinuation of the SCarletRoAD study is regrettable. Nevertheless, two trials in patients with mild Alzheimer's Disease and in genetically predisposed individuals are continuing,” said Marlies Sproll, Ph.D., CSO of MorphoSys. “MorphoSys has a very broad clinical pipeline including three programs in pivotal studies and ten in Phase II trials. Due to the breadth of our pipeline we are not dependent on the outcome of individual trials and compounds in development.”








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