Mechanism of Action: Beta Secretase Cleaving Enzyme (BACE) Inhibition
Indication: Alzheimer’s Disease
Discovery: Astex and AstraZeneca entered into a drug discovery collaboration on BACE in 2003. Assets from the collaboration were further optimized by AstraZeneca resulting in the selection of clinical candidates, including AZD3293 that have been taken into clinical development.
How this therapy can help
The progression of Alzheimer’s disease is characterized by the accumulation of amyloid plaque in the brain. BACE is an enzyme associated with the development of amyloid beta. Inhibiting BACE is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease.
AZD3293 has been shown in Phase 1 studies to reduce levels of amyloid beta in the cerebrospinal fluid of people with Alzheimer’s disease and healthy volunteers.
AZD3293 is currently being investigated in the AMARANTH Phase 2/3 clinical trial by AstraZeneca and Eli Lilly and Company (Lilly).
In addition to the continuing AMARANTH Phase 2/3 study, AstraZeneca and Lilly have also announced the planned initiation of a second Phase 3 trial for AZD3293. The trial, called DAYBREAK, is designed to study the safety and efficacy of AZD3293 in people with mild Alzheimer’s dementia, and began enrolling participants in the third quarter of 2016.
AZD3293 received Breakthrough Therapy designation from the FDA in August 2016.