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AZ gets $100m from Lilly as Alzheimer's drug progresses

BACE inhibitor candidate displays ‘encouraging’ positive safety data

AstraZeneca and Eli Lilly's candidate therapy for Alzheimer's disease (AD) has cleared a phase II/III trial and will now move on to pivotal phase III testing.

The interim analysis of the study revealed no safety issues with AZD3293 - an orally active BACE inhibitor - and the start of a registration programme has sparked a $100m milestone payment from Lilly to AZ.

The positive safety data from the AMARANTH study is encouraging but Lilly and AZ were quick to point out that this interim look at the data was not designed to give any indication of the efficacy of AZD3293, which is vying to become the first disease-modifying treatment for AD.

BACE inhibitors are designed to interfere with a cascade of molecular events that lead to the formation of neurotoxic beta amyloid deposits in the brain.

The hope is that by targeting this pathway early on in the course of the disease BACE inhibitors may improve on other amyloid-targeting drugs, which failed to show efficacy in trials involving patients in whom amyloid deposits were already present.

It is notable that other BACE inhibitors have run into toxicity problems in trials. These include Vitae Pharma and Boehringer Ingelheim's BI 1181181 which had its clinical programme suspended last year after skin rashes were seen in phase I studies, as well as Lilly's own LY2886721 which was withdrawn from development in 2013 because of liver toxicity seen in phase II trials.

Another BACE-targeting drug - Roche's RG7129 - also suffered an early demise in 2013 although the company has not been forthcoming about the reason for the termination.

The failure of LY2886721 prompted Lilly to join forces with AZ the following year in a deal that could see AZ pocket up to $500m in development and regulatory milestones.

AZ and Lilly confirmed that the phase III trial, called DAYBREAK, will study the safety and efficacy of AZD3293 in people with mild Alzheimer's dementia. It is scheduled to begin enrolling participants in the third quarter of this year.

AZ and Lilly are competing with Merck & Co, Biogen/Eisai and Novartis/Amgen in the BACE inhibitor race. Merck has its verubecestat (MK-8931) candidate in a phase II trial due to generate results early next year.

Meanwhile, Novartis and Amgen are co-developing a BACE inhibitor called CNP520 in combination with investigational immunotherapy CAD106 in people at risk of developing AD dementia, recently starting a phase II/III programme, and Eisai and Biogen are working on their E2609 candidate, which is currently in phase II.

Article by
Phil Taylor

11th April 2016

From: Research, Sales



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