In its second attempt, the antibody from the collaboration with Morphosys, which Roche is investigating in a phase III trial, also has failed. In 2014, a first phase III trial of this compound in early Alzheimer's disease (pre-dementia) was discontinued due to disappointing results. But Roche, as sponsor of the registration program, had announced in 2017 that it would stick with gantenerumab and in the summer of 2018 announced the enrollment of the first patient in a new phase III trial, with which Roche and Morphosys hoped to make a second attempt. Today, MorphoSys's licensing partner Roche has announced the status of the multi-pronged Phase III program GRADUATE for gantenerumab in early Alzheimer's disease - with the disappointing result: The studies did not meet their primary endpoint of slowing clinical decline.

However, the reduction in beta-amyloid, the protein that forms plaques in the brains of Alzheimer's patients, was lower than expected. The Phase III GRADUATE trial evaluated the safety and efficacy of gantenerumab in people with mild cognitive impairment (MCI) due to Alzheimer's disease and mild AD over a 27-month period. 1,965 study participants in 30 countries were randomized in a 1:1 ratio to receive gantenerumab or placebo by subcutaneous injection, titrated to a target dose of 510 mg and administered every two weeks. Gantenerumab is a fully human IgG1 monoclonal antibody developed in collaboration with Roche.

"We are disappointed by these results, as Alzheimer's disease affects millions of people every day," said Dr. Jean-Paul Kress, Chief Executive Officer of MorphoSys. "We are grateful to Roche, our long-time partner, for their work on the GRADUATE program and their commitment to the Alzheimer's community."

The collaboration agreement with Roche is very old, dating back to 2000, under which Roche was fully responsible for the clinical development and eventual commercialization of gantenerumab. Roche felt it was important to reaffirm its continued commitment to Alzheimer's disease. It said the company continues to develop and deliver tests that enable early and accurate Alzheimer's diagnosis and has a pipeline of investigational drugs for different targets, variants and stages of the disease.

The setback joins a host of failed attempts to eliminate amyloid plaques via an antibody-mediated immune response, or to prevent or slow their formation.