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Phase III trials of Aduhelm show benefits in Alzheimer's disease pathology at week 132.- Biogen

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Published:17th Mar 2022

Biogen announced new data showing that after nearly two and a half years of treatment (128 weeks) with Aduhelm (aducanumab-avwa) injection 100 mg/mL for intravenous use, patients in the long-term extension phase of the Phase III trials continued to experience significant reductions in two key Alzheimer’s disease pathologies, amyloid beta plaques and plasma p-tau181. The data also show that in both Phase III trials, at 78 weeks, patients with reduced levels of plasma p-tau181 had less clinical decline than those whose plasma p-tau181 levels were not reduced.

 

Data from the long-term extension study showed that Aduhelm significantly reduced amyloid beta plaque levels out to Week 132. The data also showed that Aduhelm continued to decrease plasma p-tau181 levels at 128 weeks. Patients with more effective amyloid beta clearance (SUVR lower than 1.1 by 78 weeks) also had greater decreases in p-tau181 at week 128. These findings point to the potential of continued benefit of treatment in the longer term with continued reduction of amyloid beta plaques. Data showed that patients with a reduction in plasma p-tau181, an exploratory endpoint, had less clinical progression across all four clinical endpoints (CDR-SB, MMSE, ADAS-Cog13, and ADCS-ADL-MCI) measuring cognition and function in both Phase III trials at Week 78.

In the placebo-controlled period of the Phase III trials, the incidence of ARIA-E in the 10 mg/kg group was 35.2%. The incidence was higher among APOE eta 4 carriers (43.0%) than non-carriers (20.3%). While the majority of ARIA is asymptomatic, serious symptoms in the setting of ARIA can occur (0.3% of participants in the 10 mg/kg group of the Phase III trials). Most events (98.2%) of ARIA-E resolved on study, with the majority resolving within 12-16 weeks. The long-term Phase III extension study was presented at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2022), currently underway in Barcelona, Spain, and virtually from March 15-20.

Condition: Alzheimers
Type: drug

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