Genentech has decided to suspend the CREAD 1 and CREAD 2 trials designed to study crenezumab in patients with early (prodromal to mild) sporadic Alzheimer’s disease (AD).
The decision is the result of data gained from a pre-planned interim analysis carried out by an Independent Data Monitoring Committee on the safety and efficacy of crenezumab.
The evaluation showed that crenezumab is unlikely to meet the trials’ primary endpoint of change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score.
No safety signals of crenezumab were found in the evaluation, which observed consistent overall safety profile of the drug with those revealed in previous trials.
Genentech Global Product Development head and chief medical officer Sandra Horning said: “While the results with crenezumab are disappointing, they meaningfully contribute to our understanding of Alzheimer’s disease.
“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.”
The CREAD 1 and 2 trials are Phase III, two-year global, randomised, double-blind, placebo-controlled, parallel-group studies. They are designed to test the efficacy and safety of crenezumab in 1,500 people worldwide with early AD with confirmed evidence of cerebral beta amyloid pathology (CSF or amyloid PET).