BioArctic AB, a Swedish research-based biopharma company, made an official announcement that one of its partners, Eisai Co., Ltd. (a Japanese pharmaceutical company), has started off with the global phase three confirmatory study of ‘BAN2401’ in patients affected with early stages of Alzheimer’s.
The phase 3 study, also known as Clarity AD or Study 301), that has been initiated now is a double-blind, placebo-controlled, randomized, and parallel-group study in the 1566 patients suffering from early Alzheimer’s i.e. cognitive impairment. Patients are allocated in a ratio of 1:1 to receive either treatment or placebo. In case of the treatment group, BAN2401 will be managed at a specific dosage of approximately 10 mg/kg for two times in a month.
The primary endpoint would be the change from baseline in cognition & function scale CDR-SB (Clinical Dementia Rating-Sum of Boxes) at around 18 months of treatment. The secondary endpoint would be changes in case of clinical sales ADCOMS (AD composite score) and ADAS-cog (AD Assessment Scale -Cognitive Subscale) together with the brain amyloid levels as gauged by amyloid PET.
As per Eisai, the final readout of primary endpoint is targeted by 2022. The confirmatory phase 3 will be starting after the phase 2b study of ‘BAN 2401’ in approximately 856 patients detected with the early Alzheimer’s that depicted slowing of the clinical decline with impressive tolerability after a 18-month long treatment. Eisai, BioArctic’s official partner, attained the global rights to develop as well as market ‘BAN2401’ meant for treating Alzheimer’s in 2007.
“We are extremely pleased and thrilled of the fact that the confirmatory phase 3 study with ‘BAN2401’ for early Alzheimer’s has now been initiated. There is a pre-designed plan for faster recruitment and Eisai is setting up a target of the final readout by 2022. The Phase 3 study has been designed to confirm the positive Phase 2b results in patients suffering from early Alzheimer’s. The chief objective behind ‘BAN2401’ is to arrest the rapid progression of the Alzheimer’s disease and enhance the quality of the life for the affected”, says Gunilla Osswald, CEO, BioArctic. This initiative would further help the company strengthen its product portfolio and stand out of the market competition because of its extra efforts in terms of research and development.