Disappointing Gastroenterology Clinical Trials For Aducanumab

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Each of these lesions is associated with a protein: amyloid β peptide for amyloid deposits, and phosphorylated tau protein for neurofibrillary tangles. The 4th allele of the APOE gene (APOE4 or apolipoprotein E4) is suspected to contribute to increased amyloid accumulation and is one of the major risk factors for late-onset Alzheimer’s disease.

The complexity of the evolution of Alzheimer’s disease and its fatal nature, combined with the limited effectiveness of available treatments, have placed great hopes in the development of a “miracle” drug.

Aducanumab is an anti-amyloid monoclonal antibody whose effect is to fight the soluble and insoluble forms of amyloid peptides to slow down or reduce the Gastroenterology Clinical Trials signs of dementia. In June 2021, this molecule obtained accelerated marketing approval from the US Food & Drug Administration. 

On the heels of a Phase 1b study suggesting slowing of clinical decline, Biogen researchers set up a new study based on two clinical trials – EMERGE (1638 patients) and ENGAGE (1647 patients) to study the efficacy and safety of aducanumab.

The results of these two trials – of similar design – revealed discrepancies. Neither of these two trials found significant differences in primary or secondary clinical outcomes comparing low-dose aducanumab with placebo.

The energy devoted to undertaking extensive post-hoc exploratory analyzes to attempt to explain the lack of statistical significance and discordance between trials inspires little confidence in the efficacy of aducanumab. However, one thing is now certain: the higher the doses of this active ingredient, the greater the risk of harm.