Roche to discontinue Phase III study of gantenerumab in early Alzheimer’s disease

21st December 2014 (Last Updated December 21st, 2014 18:30)

Swiss drugmaker Roche has announced its plans to discontinue SCarlet RoAD (WN25203), a Phase III study of investigational anti-amyloid medicine gantenerumab in prodromal (pre-dementia) Alzheimer’s disease.

Swiss

Swiss drugmaker Roche has announced its plans to discontinue SCarlet RoAD (WN25203), a Phase III study of investigational anti-amyloid medicine gantenerumab in prodromal (pre-dementia) Alzheimer's disease.

Gantenerumab (RG1450) is a fully human, monoclonal antibody designed to decrease levels of beta amyloid, a protein that accumulates in the brains of people with Alzheimer's disease.

The decision was based as per the recommendation by the independent Data Monitoring Committee and on the results of a pre-planned futility analysis, which found no new safety signals for gantenerumab.

The investigational drug also showed a similar overall safety profile as observed in the Phase I trial (NN19866).

Roche Global Product Development chief medical officer and head Dr Sandra Horning said: "We are disappointed with these study results because people with early stage Alzheimer's need new medicines that delay disease progression.

"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."

However, gantenerumab will be evaluated by Roche in the Phase III Marguerite RoAD study (WN28745) in a later stage of Alzheimer's disease or mild dementia.

Furthermore, the company's two investigational medicines, an anti-amyloid antibody crenezumab and a monoamine oxidase-B inhibitor RG1577, are currently in Phase II development for the disease.

Around 44 million people across the globe suffer from dementia with 7.7 million new cases registered annually. Alzheimer's disease is the most common form of dementia and is incurable.


Image: Diagram of the brain of a person (right) with Alzheimer's Disease and a normal brain (left). Photo: courtesy of Garrondo.