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news.AstraZeneca and Eli Lilly and Company have secured fast track designation from the US Food and Drug Administration (FDA) for AZD3293, an investigational treatment for early Alzheimer’s disease (AD).
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AZD3293 is an oral beta-secretase 1 cleaving enzyme (BACE) inhibitor. In theory, a BACE inhibitor would prevent the buildup of beta-amyloid and may help slow or stop AD.
In studies, AZD3293 has been demonstrated to decrease levels of amyloid beta in the cerebrospinal fluid of people with Alzheimer’s and healthy volunteers.
A phase II/III study in early AD, AMARANTH, is expected be completed in August 2019.
A second phase III trial, DAYBREAK-ALZ, in patients with mild Alzheimer's dementia is expected to commence this quarter.
AstraZeneca AZD3293 project lead in global medicines development Craig Shering said: “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.
“BACE inhibitors have the potential to transform the treatment of Alzheimer’s disease, one of the biggest challenges facing medical science today.”
AZD3293 is being co-developed and co-commercialized by Eli Lilly and AstraZeneca under their 2014 strategic alliance.
Lilly leads clinical development, assisted by AstraZeneca's neuroscience research and development team.
AstraZeneca will be responsible for manufacturing. Both the companies will equally share future costs for development and commercialization as well as net revenues after launch.