MorphoSys AG has announced that its partner Roche plans to initiate a new pivotal phase 3 program for gantenerumab in patients with prodromal to mild Alzheimer’s disease (AD). Gantenerumab is a monoclonal antibody directed against beta amyloid.
MorphoSys was informed that Roche intends to begin preparations for two studies and expects to start the program later this year. Further information, including details of the trials, was not available.
After its first phase 3 study ended in failure in 2014, Roche vowed to press on with testing gantenerumab at higher doses, saying it would consult with regulators about the design for new trials, according to a report from FierceBiotech
The 2014 gantenerumab study missed both its primary and secondary efficacy endpoints, but after further analysis, Roche said there was a trend toward a benefit in patients whose dementia progressed most quickly. The company started phase 1 trials of a new high-concentration liquid formulation of gantenerumab last year with the aim of showing that a higher dose would be safe enough to bring forward into phase 3.
Nevertheless, it’s a high-risk move by Roche, coming after the much-anticipated Expedition 3 trial of Eli Lilly’s solanezumab followed the same course as two earlier studies and ended in failure, the FierceBiotech article says. Pfizer had a similar outcome with its amyloid-targeting antibody bapineuzumab, and a beta secretase-cleaving enzyme (BACE) inhibitor from Merck—designed to interrupt the amyloid pathway further upstream—also fell at the phase 3 stage.
Roche has also started a second phase-3 trial of another anti-amyloid candidate—crenezumab—despite its lackluster performance in a phase 2b trial. Data from the phase 3 study aren’t expected until 2020.