Roche, MorphoSys Plan Experimental Clinical Trials of Gantenerumab for Alzheimer’s

Roche and MorphoSys will partner on experimental Phase 3 clinical trials to study the effectiveness and safety of gantenerumab in patients with early to mild Alzheimer’s disease.

Roche, a Swiss global healthcare company, will start preparing two studies soon, according to MorphoSys, a German biotechnology company that developed gantenerumab. The trials will start this year, MorphoSys added.

Gantenerumab is an antibody against the beta-amyloid protein that accumulates in the neurons of people with Alzheimer’s. MorphoSys used its proprietary HuCAL antibody library technology to develop the therapy.

HuCAL allows scientists to make rapid discoveries of antibodies that can be tested against several diseases, including Alzheimer’s, cancer and rheumatoid arthritis.

“This is great news for MorphoSys,” Marlies Sproll, the company’s chief scientific officer, said in a press release. “We are delighted by the strong commitment to gantenerumab as a potential new therapy for Alzheimer’s disease.”

“The HuCAL-derived antibody gantenerumab has properties that we believe make it a promising candidate to treat Alzheimer’s disease, and we look forward to learning more about these new phase 3 trials,” Sproll added.

Roche and MorphoSys were partners on another Phase 3 trial, SCarletRoAD (NCT01224106), which investigated the effectiveness and safety of gantenerumab in patients with early Alzheimer’s. The partners  discontinued the trial because of difficulty determining the therapy’s safety, although no new safety signal arose.

Participants in the trail were randomized to receive injections of either gantenerumab or a placebo. Positron emission tomography (PET) scanning was used to assess improvement in beta-amyloid levels.

The study’s primary measuring stick was the mean change in patients’ scores on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) scale between the start of the trial and 104 weeks of treatment.

Alzheimer’s disease is caused by an accumulation of faulty proteins, such as beta-amyloid or tau. They interfere with proper neuronal activity, a deterioration that is directly associated with cognitive decline in Alzheimer’s patients.

There is no approved treatment for Alzheimer’s. Several experimental treatments are being tested, however.