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Main | | | | | | | | |
| Brand | BAN2401 | | | | | | |
| Generic | lecanemab | | | | | | |
| MOA | anti-AB protofibril antibody | | | | | | |
| Clinical Trials | | | | | | | |
| | Phase III "CLARITY" n=1906 early Alzheimer's - NCT03887455, full results at CTAD 11/29/22 | | | | | | |
| | PE: CDR-SB at 18 months | | | | | | |
| | 10mg/kg q2w, 720mg subcutaneous qw | | | | 1.6666666666666665 | 1.2166666666666666 | at 18 weeks - but what was baseline? 3.5 (donanemab) or 6.7 (donepezil) |
| | File for approval by 3/31/23. | | | | | | 1.42/year in Aricept |
| | -0.45 p=0.00005 at 18 months ("Lecanemab treatment met the primary endpoint and reduced clinical decline on the global cognitive and functional scale, CDR-SB, compared with placebo at 18 months by 27%, which represents a treatment difference in the score change of -0.45 (p=0.00005) in the analysis of Intent-to-treat (ITT) population.") | | | | | | |
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| | Phase III "AHEAD 3-45" n=1400 - NCT04468659 | | | | | | |
| | PACC5 PE at 4 years(!!) | | | | | | |
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| | Phase II "Study 201" | | | | | | |