AstraZeneca and Eli Lilly to enter Phase III on Alzheimer’s clinical trials

pharmafile | April 8, 2016 | News story | Medical Communications |  AZD3293, Alzheimer’s, Alzheimers, AstraZeneca, amaranth, clinical trial, lilly, phase III 

AstraZeneca and Eli Lilly have announced the continuation of their clinical trial for people with early Alzheimer’s disease into Phase III, after an independent monitoring committee recommended the study’s continuation.

The AMARANTH clinical trial is Phase II/III study of AZD3293, an enzyme inhibitor that 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 is characterised by the accumulation of amyloid plaque in the brain and inhibiting the beta secretase cleaving enzyme (BACE) which is associated with the formation of amyloid beta, as this drug candidate does, is expected to prevent the formation of amyloid plaque and ultimately slow the progression of the disease.

Menelas Pangalos, executive VP of the IMED Biotech Unit at AstraZeneca, says: “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.”

Phyllis Ferrell, global development leader in Alzheimer’s disease at Lilly, comments: “This is an important and meaningful step on the path to better understand the Alzheimer’s puzzle.”

The pharmaceutical giants have also announced the planned initiation of new Phase III trial, called DAYBREAK, to study the efficacy the safety and efficacy of AZD3293 in people with mild Alzheimer’s dementia.

The alliance between the two was announced in 2014, with Lilly leading the clinical development working alongside researchers from AstraZeneca’s Neuroscience Research and Development Team, with the latter responsible for manufacturing. Joint responsibility will be taken for commercialisation, and the future costs and global revenues shall also be shared.

Sean Murray