AstraZeneca and Eli Lilly’s experimental Alzheimer’s disease drug AZD3293 has been issued a Fast Track designation in the US potentially speeding up the drug regulatory pathway.
AZD3293 is an oral beta secretase cleaving enzyme (BACE) inhibitor shown in studies to reduce levels of amyloid beta in the cerebrospinal fluid of people with Alzheimer’s and healthy volunteers, raising hopes that it might prove to be an effective new treatment target.
The drug is currently being tested in the Phase II/III AMARANTH study, as well as the Phase III DAYBREAK-ALZ trial, which recently began enrolling patients with mild Alzheimer’s dementia.
“The Fast Track Designation in the US for this promising potential therapy reinforces the ambition of the AstraZeneca-Lilly BACE Alliance to advance science for patients and their families managing this devastating illness,” noted Craig Shering, AZD3293 project lead in global medicines development at AZ. “BACE inhibitors have the potential to transform the treatment of Alzheimer’s disease, one of the biggest challenges facing medical science today.”
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.
