CAMBRIDGE, Mass. - Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) announced that data from approximately 7,000 plasma samples from more than 1,800 patients in the ADUHELM (aducanumab-avwa) Phase 3 clinical trials showed a statistically significant correlation between plasma p-tau reduction and less cognitive and functional decline in Alzheimer's disease. Reductions in plasma p-tau181 were also correlated with a lowering of amyloid beta plaque. The pre-specified analysis of plasma samples was conducted by an independent lab, drawing from the two pivotal ADUHELM Phase 3 EMERGE and ENGAGE trials. The findings were presented today at the Clinical Trials on Alzheimer's Disease conference (CTAD), held November 9-12 virtually and in Boston, Massachusetts.

The analysis highlighted that ADUHELM significantly reduced tau pathology, a defining feature of Alzheimer's disease, as measured by plasma p-tau181, when compared to placebo. The effect was greater with higher doses and longer duration of ADUHELM treatment. Greater reduction in plasma p-tau181 also had a statistically significant correlation with less decline in cognition and function in ADUHELM-treated patients. Furthermore, the analysis demonstrated a statistically significant correlation between change in plasma p-tau181 and lowering of amyloid beta plaque, showing the effect of ADUHELM on the two core pathological features of Alzheimer's disease.

'We now have robust and concordant data that ADUHELM has effect on two core defining pathologies of Alzheimer's disease, and substantial evidence of treatment correlation between changes in plasma p-tau181 and the slowing of disease progression,' said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. 'We are committed to continuing to generate data, and we believe these new findings can help inform treatment choice and advance Alzheimer's research including in diagnosis and disease monitoring.'

The findings showed that ADUHELM significantly lowered plasma p-tau181 in a dose- and time-dependent manner vs. placebo in both Phase 3 trials. In the EMERGE high-dose group, p-tau decreased 13% from baseline (p

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