AstraZeneca and Eli Lilly’s experimental Alzheimer’s disease drug AZD3293 has been given the green light to progress into late-stage testing, after a safety analysis by an independent data monitoring committee.
The decision means that the closely-watched drug, an oral beta secretase cleaving enzyme (BACE) inhibitor, can continue seamlessly into the Phase III section of the ongoing Phase II/III AMARANTH trial.
“This is an important and meaningful step forward on the path to better understand the Alzheimer’s puzzle,” noted Phyllis Ferrell, vice president and global development leader for Alzheimer’s disease at Lilly.
BACE is an enzyme associated with the development of beta-amyloid, and its inhibition is expected to eventually slow progression of the disease.
In Phase I trials, AZD3293, also known as LY3314814, reduced levels of amyloid-beta in the cerebro-spinal fluid of Alzheimer’s patients and healthy volunteers, raising hopes that it might prove to be an effective new treatment target.
AZ and Lilly also announced the planned start of a new Phase III trial for AZD3293, named DAYBREAK, in the third quarter, to study its safety and efficacy in people with mild Alzheimer’s dementia.
The companies have been collaborating on the drug’s development since 2014. Under the terms of their agreement, Lilly leads clinical development, working with AZ researchers, while the Anglo-Swedish drugmaker will be responsible for manufacturing.
Both groups have joint responsibility for commercialisation and will share all future costs equally for development and commercialisation, as well as net global revenues post-launch.