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Roche's Genentech to begin new Phase III trial of Alzheimer's drug.

M2 PHARMA-March 1, 2017-Roche's Genentech to begin new Phase III trial of Alzheimer's drug


Following on from the promising data on the drug's "unique" binding properties and in support of increased dosing, Roche AG's (VTX: ROG) subsidiary Genentech will begin a second Phase III trial of anti-Abeta antibody crenezumab in patients with early forms of Alzheimer's disease (AD), Pharma Times reported on Wednesday.

For the new trial, CREAD2, the company plans on recruiting 750 patients with prodromal or mild AD. It will complement the ongoing Phase III CREAD1 trial, which is assessing the drug in the same patient group. The results from this first Phase III trial are expected to be announced in 2020.

Crenezumab is a fully humanised IgG4 monoclonal antibody that binds all forms of misfolded Abeta proteins to prevent and break up their aggregation and promote their disaggregation. It was discovered by AC Immune (NASDAQ: ACIU) through the use of its SupraAntigen technology platform and was then out-licensed to Genentech in 2006 as a potential therapy for Alzheimer's.

While data presented by Roche in 2014 from two Phase II trials investigating whether crenezumab can delay cognitive and functional decline in people with mild-to-moderate AD showed that proof-of-concept study failed to meet its primary endpoint, the study did demonstrate initial evidence of a crenezumab treatment effect in people with mild AD. Similar effects on clinical decline were observed in BLAZE, a smaller biomarker study.

The decision to launch a second Phase III trial suggests a continued confidence in the drug.

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Publication:M2 Pharma
Date:Mar 1, 2017
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