Phase II/III trial of AZD3293 in early Alzheimer’s disease to continue

AstraZeneca and Lilly have announced that AMARANTH, a Phase II/III study of AZD3293 will continue into Phase III of the Phase II/III seamless trial.

AZD3293 is an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for early Alzheimer’s disease.

AMARANTH is a Phase II/III study that is investigating the safety and efficacy of AZD3293 and testing the hypothesis that it is a disease-modifying treatment for patients with early Alzheimer’s disease. Early Alzheimer’s disease is defined as the continuum of patients with mild cognitive impairment (MCI) due to Alzheimer’s disease and patients diagnosed with mild Alzheimer’s dementia. The study, which has a two-year treatment period, aims to enrol more than 2200 patients in 14 countries. The AMARANTH independent data monitoring committee recommended the study continue without modification after a scheduled interim safety analysis was conducted.

Commenting on the continuation of the trial, Menelas Pangalos, Executive Vice President, IMED Biotech Unit, AstraZeneca, said: “Alzheimer’s disease remains one of the biggest challenges facing medical science today. BACE inhibitors have the potential to target one of the key drivers of disease progression and we are delighted that our combined efforts have resulted in the development of AZD3293 moving into the next phase of study. Disease modifying approaches, such as this, have the potential to transform the treatment of Alzheimer’s disease and help patients in this area of large unmet medical need.”

Phyllis Ferrell, vice president and global development leader for Alzheimer’s disease at Lilly, said: “This is an important and meaningful step forward on the path to better understand the Alzheimer’s puzzle. We’d like to thank the AMARANTH participants and the trial investigators for taking part in this important study and thank our colleagues at AstraZeneca for their partnership.”

AZD3293 to be assessed in people with mild Alzheimer’s dementia

AZD3293 has been shown in Phase I studies to reduce levels of amyloid beta in the cerebro-spinal fluid of people with Alzheimer’s disease and healthy volunteers. The progression of Alzheimer’s disease is characterised 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.

AstraZeneca and Lilly have also announced the planned initiation of a new Phase III trial for AZD3293. The trial, named DAYBREAK, will study the safety and efficacy of AZD3293 in people with mild Alzheimer’s dementia. DAYBREAK will begin enrolling participants in the third quarter of 2016.