- Eisai Co Ltd ESALY and Biogen Inc BIIB announced that three additional detailed analyses from the Phase IIb clinical study (Study 201) of lecanemab for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD were published in the peer-reviewed journals.
- In the core 201 study, lecanemab was shown to reduce brain Aβ accumulation measured by amyloid PET in a dose- and time-dependent manner after 12 and 18 months of treatment, and corresponding changes in plasma biomarkers and reduction in clinical decline.
- During the gap period, a trend was observed for plasma Aβ42/40 ratio and p-tau181 values to return to the pre-administration levels (re-accumulation) faster than amyloid PET.
- Also Read: Alzheimer's Association Launches Grassroots Level Lobbying For Medicare Coverage Of Alzheimer's Treatments.
- In the OLE, lecanemab 10 mg/kg biweekly treatment showed a decrease in brain amyloid beta (Aβ) accumulation measured by amyloid PET, a decrease in the plasma Aβ42/40 ratio, and a decrease in plasma p-tau181.
- In the core study 201, amyloid-related imaging abnormalities-edema (ARIA-E) was dose-dependent, with an incidence of 9.9% at the highest doses (10 mg/kg bi-weekly) for the overall population and 14.3% for ApoE4 positive subjects.
- PK/PD modeling showed that the incidence of ARIA-E was correlated with Cmax at a steady state. A subcutaneous formulation that may potentially reduce the Cmax of lecanemab is being developed and evaluated to determine if the incidence of ARIA-E is reduced compared to the intravenous formulation.
- Price Action: BIIB shares closed at $274.01 on Thursday.
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