On 17 July, Eisai presented new data from the BAN2401 Phase II study at the Alzheimer’s Association International Conference (AAIC) in Los Angeles (US). The 18-months Phase II clinical trial is a placebo-controlled, double-blind, parallel-group and randomised study to evaluate the safety and efficacy of BAN2401, a drug targeting beta amyloid, in 856 participants with early Alzheimer’s disease (AD).
The presentation suggested that BAN2401 is associated with reduced neurodegeneration. Biomarkers of neurodegeneration showed a decrease of tau pathology after both 12- and 18-months treatment. Increased BAN2401 exposure measured by serum concentrations were also correlated with reductions of amyloid beta in the brain. All data were consistent with the previously presented findings. BAN2401 is being jointly developed by Eisai and Biogen in a Phase III study (Clarity AD) in people with early AD.
In addition, Eisai presented information about elenbecestat, an oral BACE inhibitor. A Data Safety Monitoring Board has reviewed the safety data and recommended the continuation of the ongoing MISSIONAD1 and MISSION AD2 Phase III studies investigating elenbecestat in people with early Alzheimer's disease. Furthermore, researchers reported that elenbecestat (50 mg) showed a significant reduction in brain amyloid load at 18 months versus the placebo group in people with mild cognitive impairment due to AD, or mild-to-moderate dementia due to AD with confirmed amyloid pathology by positron emission tomography in the Phase II study, named Study 202.
