Genentech has decided to discontinue Phase 3 studies of an investigational Alzheimer disease (AD) treatment in patients with early sporadic AD.
The CREAD 1 and 2 studies were designed to assess the safety and efficacy of crenezumab, an investigational monoclonal antibody that preferentially binds to and promotes the removal of neurotoxic oligomers, a form of beta-amyloid. The studies included patients with early AD with confirmed evidence of cerebral beta amyloid pathology. However, results from a pre-planned interim analysis showed that the drug was unlikely to meet the primary endpoint of change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score.
The Company will continue to study crenezumab in a separate, 5-year study (Alzheimer’s Prevention Initiative) involving cognitively healthy individuals with an autosomal dominant mutation that puts them at risk for developing familial AD.
Speaking on the decision to end the CREAD trials, Sandra Horning, MD, chief medical officer of Genentech Global Product Development said, “We remain dedicated to the Alzheimer’s community and will continue our Phase 3 Graduate trials with gantenerumab and the Phase 2 Tauriel trial with the anti-tau molecule RG6100, as well as our imaging and fluid-based diagnostic solutions.”
The full findings from the CREAD trials will be shared at an upcoming medical congress.
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