The FDA designates Phase 3-stage AZD3293 for Fast Track review for the treatment of early Alzheimer's disease (AD). AZD3293 inhibits an enzyme called BACE (beta secretase cleaving enzyme) which plays a key role in the formation of myelin sheaths in peripheral nerve cells. In theory, inhibiting BACE will prevent the accumulation of beta-amyloid and slow the progression of AD.
A Phase 2/3 study in early AD, AMARANTH, should be completed in August 2019. The primary endpoint is the change from baseline in Clinical Dementia Rating at Week 104. A second Phase 3, DAYBREAK-ALZ, in patients with mild Alzheimer's dementia should commence this quarter. Its primary endpoint is the change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale Score at Week 78. According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is August 2019. The estimated study completion date is April 2021.
Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the New Drug Application (NDA).
AZD3293 is being co-developed and will be co-commercialized by Eli Lilly (NYSE:LLY) and AstraZeneca (NYSE:AZN) under their 2014 strategic alliance. Lilly leads clinical development, assisted by AstraZeneca's Neuroscience Research and Development Team, while AstraZeneca will be responsible for manufacturing. Both firms will commercialize and will equally share future costs for development and commercialization as well as net revenues after launch.
Previously: Lilly and AstraZeneca Alzheimer's candidate advances; AstraZeneca earns $100M milestone (April 8)
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