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Korea approves phase 3 trials of Lilly’s Alzheimer’s therapy

Lee Hye-seon  Published 2017.08.08  15:10  Updated 2017.08.08 15:10

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The Ministry of Food and Drug Safety has approved the extended phase 3 clinical trials for early-stage Alzheimer’s therapy Lanabecestat (clinical trial medication LY3314814/AZD3293) which are being developed by Lilly릴리 and Astrazeneca아스트라제네카.

Researchers will design the trials as randomized, double-blind tests and conduct them on 100 early-stage Alzheimer’s patients.

Lilly is doing AMARANTH research that combines the phase 2 and 3 trials of related compounds, and the trial approved this time the extension of AZES studies (I8D-MC-AZES (NCT02245737)).

Lilly and Astrazeneca are now conducting AMARANTH and DAYBREAK researches to confirm LY3314814 (AZD3293)’s treatment effect of the Alzheimer’s.

The exact cause and pathogenesis of Alzheimer’s have not been confirmed, but the accumulation of the beta amyloid protein reportedly causes the disease. Accordingly, the pathogenesis to control the protein is drawing attention.

LY3314814 (AZD3293) is the compound that deters beta secretase enzyme BACE 1 related to the creation of beta amyloid. In the phase 1 trial for Alzheimer’s patients and healthy people, the drug decreased the accumulation of beta amyloid in the cerebrospinal fluid. In 2016, the U.S. Food and Drug Administration (FDA) designated the drug as subject to fast-track screening.

Lilly is responsible for conducting clinical trials of LY3314814 (AZD3293) and developing it, and Astrazeneca will manufacture it. If the development is completed, the two companies will commercialize the drug together.

lhs@docdocdoc.co.kr

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