Lilly/AZ's Alzheimer's drug gets fast US development

Eli Lilly and AstraZeneca’s late-stage Alzheimer’s drug is to get faster development in the US, the companies have announced.

AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor is to get a Fast Track review, where the US Food and Drug Administration expedites development and review of new therapies to treat serious conditions or to tackle unmet medical needs.

The phase 2/3 AMARANTH study is ongoing, but the companies have begun a second phase 3 trial called DAYBREAK-ALZ, which studies safety and efficacy of AZD3293 in people with mild Alzheimer’s and dementia.

AZD3293 has been shown in studies to reduce levels of amyloid beta in the cerebro-spinal fluid of people with Alzheimer’s and healthy volunteers.

Progression of Alzheimer’s disease is associated with accumulation of amyloid plaque in the brain. Inhibiting BACE, an enzyme associated with development of amyloid beta, is expected to prevent formation and build-up of these plaques, which may help slow disease progression.

AstraZeneca (AZ) and Lilly formed an alliance to develop AZD3293 in 2014. Lilly is leading clinical development, working with researchers from AZ, which is responsible for manufacturing.

The companies will co-market the drug if approved, sharing development and commercialisation costs equally, as well as net global revenues.

Although many treatments for Alzheimer's have failed, the rewards for a drug that slows progression will be significant due to the size of the patient population.

AZ has predicted sales of around $5 billion by 2023 if approved, as part of an ambitious plan by chief executive Pascal Soriot to achieve annual revenues of greater than $45 billion by that time.

Lilly is already developing solanezumab in phase 3 for Alzheimer’s, which works by binding to amyloid in order to prevent it from forming plaques.

Biogen is also developing an Alzheimer’s drug, aducanumab, which is in late stage development.

Following a slew of late-stage trial failures a few years ago, development of new Alzheimer’s drugs has been slow.

Eisai’s now-genericised Aricept (donepezil), rivastigmine and memantine are commonly used therapies, which have very limited effect on disease progression.