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Biogen says trial extension data keep Alzheimer's drug on track

Releases updated results from the PRIME trial of anti-amyloid drug aducanumab


Biogen has continued to drip feed positive data on its Alzheimer's candidate aducanumab, and now says a long-term extension of its phase Ib trial back up its decision to push into phase III with the drug.

The updated results from the PRIME trial of aducanumab - an anti-amyloid drug - now includes data from early Alzheimer's disease patients who have been taking the drug for two to three years, and suggest that they are continuing to see a benefit on the rate of clinical decline, as measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) and Mini-Mental State Examination (MMSE) scales.

The new analysis involve a group of patients who received a titrated dose of the drug for two years, and a fixed-dose group treated for three years. In both cases, the benefits on CDR-SB and MMSE extended into the second and third years and tracked significant decreases in amyloid plaque in the brains of patients.

The incidence of the most significant side effect seen with aducanumab - ARIA-E (a form of oedema in the brain) - remained in line with earlier data on the drug and according to Biogen was "typically asymptomatic, and most patients continued in the study".

The results comes from a small study of just over 190 patients, so should be interpreted with caution, particularly as there is a long list of amyloid-targeting drugs have been abandoned for failing to reduce the decline in memory and cognition that accompany Alzheimer's disease, including Eli Lilly's solanezumab. With each failure, voices suggesting the hypothesis that amyloid deposits drive the disease is flawed get a little louder.

But with great risk comes the potential for great reward, and EvaluatePharma recently suggested that aducanumab could be the most valuable drug in pharma's pipeline if it makes it through to regulatory approval. The drug has already been entered into the EMA's PRIME programme, and been fast-tracked by the FDA and Japanese regulatory authorities.

Aducanumab is currently being evaluated in two global Phase III studies, ENGAGE and EMERGE, with the first data emerging sometime after 2020. If all goes according to plan EvaluatePharma thinks aducanumab could quickly rack up $1.5bn or more in sales by 2022, with plenty of further growth to come.

In the wake of the solanezymab disappointment, SI Evercore analyst John Scotti said it seems aducanumab removes around ten times as much amyloid in the CNS as Lilly's drug, saying the negative trial had "minimal to no negative read across to the amyloid hypothesis".

Aducanumab acts differently than solanezumab, which was designed to mop up the peptide in the blood rather than break down already-formed amyloid plaques in the central nervous system directly.

Article by
Phil Taylor

30th August 2017

From: Research



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