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AstraZeneca and Eli Lilly BACE Inhibitor (Alzheimer’s Disease) Move to Final Stage of Clinical Trials

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AstraZeneca (United Kingdom) and Eli Lilly (United States) jointly announced, their Beta-secretase 1 (BACE 1 inhibitor)- AZD3239, for Alzheimer’s disease (AD) treatment came out with flying colors in its safety profile analysis and now moved further for Phase III clinical trials.

The Phase II/III study AMARANTH determined the safety and efficacy of AZD3239 in early AD dementia patient. The Phase III trial DAYBREAK will investigate the safety and efficacy of AZD3239 in mild AD dementia patient. The enrollment of the volunteers will begin in the third quarter of 2016. Both the companies have jointly agreed on sharing the responsibilities of commercialization of the molecule and sharing the future expenses of its development and commercialization equally. The AstraZeneca will further receive a milestone payment of $100 million from Eli Lilly as Externalization Revenue.

AD has been marked by the accumulation of β-amyloid (Aβ)-protein fragments in the brain. It is produced by the fragmentation of a larger protein– amyloid precursor protein (APP) by two enzymes, BACE and γ-secretase. Therefore inhibition of BACE enzyme can lead to the inhibition of accumulation of Aβ in the brain leading to the halt of progression of AD and thus could serve a vital role in the arrest of AD in the patients.

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.”

This is not the first collaboration between AstraZeneca and Eli Lilly for BACE inhibitors development. In 2014, they had entered into an agreement to jointly develop and commercialize, AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor for treatment of mild to moderate AD.

In 2013, Eli Lilly suffered a setback in its own BACE program and terminated their Phase II trial of the BACE inhibitor-LY2886721 after it was found toxic in liver tests.

BACE inhibitors have attracted the attention of the researchers as a potential therapeutics for the treatment of AD. Many disappointing results came for the BACE inhibitors but the efforts put forth by the companies is really on its way towards a breakthrough BACE inhibitor for AD.

Featured image credit: Conceptual image of human brain in colorful splashes © Sergey Nivens (Stock Photo ID: 72022081)

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