AZ and Lilly Alzheimer’s drug enters trials
pharmafile | December 1, 2014 | News story | Research and Development, Sales and Marketing | AZD3293, Alzheimer's, AstraZeneca, LY3314814, lilly
AstraZeneca and Eli Lilly have begun a Phase II/II trial for their Alzheimer’s treatment AZD3293 as the companies hope to buck the trend of past failures in the area.
The AMARANTH study will test the compound in more than 1,500 early Alzheimer’s patients across 15 countries, with a treatment period of two years.
AZD3293 – also known as LY3314814 – is an inhibitor of beta secretase cleaving enzyme (BACE). By blocking BACE, the firms hope that the medicine will prevent the formation of amyloid plaques in the brain, which is believed to contribute towards the progression of Alzheimer’s.
In Phase I studies the drug has been shown to reduce levels of amyloid-beta, responsible for amyloid plaques, in the cerebro-spinal fluid of both Alzheimer’s patients and healthy volunteers.
“There is a critical need to develop new medicines that can change the course of Alzheimer’s disease,” says Samantha Budd, vice president and head of translational science in AstraZeneca’s Neuroscience Innovative Medicines unit. “We believe that BACE inhibitors have the potential to target one of the key drivers of this devastating disease.”
There is another promising area of Alzheimer’s research that the drug ignores, however – the build-up of tau protein that forms tau tangles inside neurons.
There have also been several past failures when testing the amyloid hypothesis. Solanezumab, also from Lilly, and bapineuzumab from Pfizer and Johnson & Johnson both failed late-stage trials in 2012.
This high failure rate of Alzheimer treatments has led AZ to give AZD3293 only a 9% chance of success on a risk-adjusted basis, and is perhaps a driving reason behind the UK firm’s decision to team up with US rival Lilly.
The companies first announced their collaboration in September, saying that they hoped to progress AZD3293 into Phase II/III trials ‘rapidly’.
Under the terms of the agreement, Lilly will lead clinical development of AZD3293, working with researchers from AZ’s Neuroscience Innovative Medicines Unit, while AZ will be responsible for manufacturing.
Lilly will pay AstraZeneca up to $500 million in development and regulatory milestones. The firms will take joint responsibility for commercialisation and will share in all future costs and revenues.
George Underwood
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