Roche’s Genentech has decided to stop two phase 3 trials evaluating its anti-beta-amyloid molecule crenezumab in early Alzheimer’s disease (AD) for futility reasons.
The two trials, dubbed CREAD 1 and CREAD 2, will be discontinued as a pre-planned interim analysis indicated that crenezumab was not likely to meet their primary endpoint, which was defined as change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score.
The late-stage trials were assessing the safety and efficacy of the anti-beta-amyloid molecule in people with early (prodromal to mild) sporadic AD.
Genentech said that no safety signals for the investigational candidate were seen in the interim analysis, and the overall safety profile was in line with that seen in previous clinical trials.
The two-year CREAD 1 and 2 trials enrolled a total of 1,500 people across the world with early AD. The two trials used doses four times more than what was tested in the phase 2 trials.
Genentech chief medical officer and global product development head Sandra Horning said: “While the results with crenezumab are disappointing, they meaningfully contribute to our understanding of Alzheimer’s disease.
“We gratefully acknowledge the participants in the CREAD trials and the efforts of everyone involved in this important program. We remain dedicated to the Alzheimer’s community and will continue our Phase III GRADUATE trials with gantenerumab and the Phase II TAURIEL trial with the anti-tau molecule RG6100, as well as our imaging and fluid-based diagnostic solutions.”
Genentech said that it will continue to study crenezumab in the Alzheimer’s Prevention Initiative (API) trial in Colombia, which will feature cognitively healthy individuals having an autosomal dominant mutation and are prone to developing familial AD (fAD).
Discovered by AC Immune, a Swiss biotechnology company, Crenezumab is a monoclonal antibody designed to selectively bind to and promote removal of neurotoxic oligomers.
Genentech and Roche have over a dozen investigational drug in clinical development for neurological diseases like multiple sclerosis, AD, spinal muscular atrophy, Huntington’s disease, Parkinson’s disease and autism spectrum disorder.