8th Apr 2016 06:16
LONDON (Alliance News) - Biopharmaceutical business AstraZeneca PLC and healthcare company Eli Lilly & Co on Friday said they will continue with a clinical trial for a potential treatment for early Alzheimer's disease, the most common form of dementia.
Amaranth, a Phase II/III study of AZD3293, an oral beta secretase cleaving enzyme inhibitor in development as a potential treatment for early Alzheimer's disease, will continue into Phase III of the Phase II/III seamless trial, according to a statement.
Under the terms of the agreement, AstraZeneca will receive a further milestone payment from Eli Lilly now that AZD3293 will move into Phase III testing. The payment of USD100 million will be reported as externalisation revenue in AstraZeneca's financial statements, and the company said it does not change its financial guidance for 2016.
The Amaranth independent data monitoring committee recommended the study continue "without modification", following a scheduled interim safety analysis. The analysis was not designed to review efficacy.
"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," Menelas Pangalos, executive vice president, IMED Biotech Unit, AstraZeneca, said in the statement.
"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," Pangalos said.
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 companies said.
The progression of Alzheimer's disease is characterised by the "accumulation" of amyloid plaque in the brain. Beta secretase cleaving enzyme is associated with the development of amyloid beta. Inhibiting b is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease.
"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," said Phyllis Ferrell, vice president and global development leader for Alzheimer's disease at Eli Lilly.
AstraZeneca and Eli Lilly 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. The trial will begin enrolling participants in the third quarter of 2016.
By Samuel Agini; [email protected]; @samuelagini
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