Biogen Paper, page-2

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pierre77

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19/07/16

09:09

Post #: 18303584
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Originally posted by interestingtome ↑

First-in-human, double-blind, placebo-controlled, single-dose escalation study of aducanumab (BIIB037) in mild-to-moderate Alzheimer's disease

James Ferrero, et al.
Abstract

Introduction
Aducanumab (BIIB037), a human monoclonal antibody selective for aggregated forms of amyloid beta, is being investigated as a disease-modifying treatment for Alzheimer's disease (AD).
Methods

This randomized, double-blind, placebo-controlled single ascending-dose study investigated the safety, tolerability, and pharmacokinetics (PK) of aducanumab in patients with mild-to-moderate AD. Eligible patients were sequentially randomized 6:2 to aducanumab (0.3, 1, 3, 10, 20, 30, and 60 mg/kg) or placebo.
Results

The primary outcome was safety and tolerability. Doses ≤30 mg/kg were generally well tolerated with no severe or serious adverse events (SAEs). All three patients who received 60-mg/kg aducanumab developed SAEs of symptomatic amyloid-related imaging abnormalities, which completely resolved by weeks 8–15. Aducanumab C_max, AUC_0–last, and AUC_inf increased in a dose-proportional manner.
Discussion

In this single-dose study, aducanumab demonstrated an acceptable safety and tolerability profile and linear PK at doses ≤30 mg/kg (clinicaltrials.gov NCT01397539).

"Although there was an increase in plasma levels of Ab40 and Ab42 at 60 mg/kg, aducanumab did not appear
to significantly affect plasma levels of Ab40 or Ab42 at the lower doses (0.3 mg/kg to 30 mg/kg). The largely unaffected soluble Ab levels are consistent with the very low affinity of aducanumab for soluble monomeric Ab. At 60 mg/kg, both Ab40 and Ab42 also demonstrated higher baseline/pre-dose values and higher patient variability than the lower dose cohort patients, thus complicating the interpretation. No dose-dependent response was observed for change in mean ADAS-Cog 13 scores after single-dose administration of aducanumab."

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We all know who brought up Biogen on this board .. About how great the company was when compared to Prana and how promptly their Management was going to fix its issues haha

Looking forward to a discussion about that attached paper.. Any thoughts?

Last edited by pierre77: 19/07/16

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Biogen Paper, page-2

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Biogen Paper, page-2

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